Medical device for modification of left atrial appendage and related systems and methods

ABSTRACT

Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a device includes a framework extending between a primary hub and a secondary hub. The secondary hub is moveable relative to the primary hub upon deploying the framework from a constricted position to a deployed position such that the secondary hub remains proximal a distal end of the framework. The framework, in the deployed position, includes engaging members proximal the distal end of the framework, and the framework includes multiple frame segments each extending with an arcuate configuration at a distal side of the framework such that the frame segments, at the distal side thereof, each extend radially and distally toward the distal end, then turn and extend radially and proximally inward toward the secondary hub.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 12/818,059 filed on Jun. 17, 2010, which claims the benefit ofU.S. Provisional Patent Application No. 61/218,018 filed Jun. 17, 2009,U.S. Provisional Patent Application No. 61/294,058 filed Jan. 11, 2010,U.S. Provisional Patent Application No. 61/320,635 filed Apr. 2, 2010,U.S. Provisional Patent Application No. 61/325,230 filed Apr. 16, 2010and U.S. Provisional Patent Application No. 61/345,514 filed May 17,2010, the disclosures of each of which are incorporated by referenceherein in their entireties.

The present application is also related to U.S. patent application Ser.No. 12/818,041; U.S. patent application Ser. No. 12/818,053; and U.S.patent application Ser. No. 12/818,059, each of which were filed on thesame date as U.S. patent application Ser. No. 12/818,046, thedisclosures of each which are also incorporated by reference herein intheir entireties.

TECHNICAL FIELD

The present invention relates generally to the occlusion or modificationof tissue openings or appendages and, more specifically, to devices,systems and methods for occluding or otherwise structurally alteringsuch openings and appendages including, for example, left atrialappendages.

BACKGROUND

The upper chambers of the heart, the atria, have appendages attached toeach of them. For example, the left atrial appendage is a feature of allhuman hearts. The physiologic function of such appendages is notcompletely understood, but they do act as a filling reservoir during thenormal pumping of the heart. The appendages typically protrude from theatria and cover an external portion of the atria. Atrial appendagesdiffer substantially from one to another. For example, one atrialappendage may be configured as a tapered protrusion while another atrialappendage may be configured as a re-entrant, sock-like hole. The innersurface of an appendage is conventionally trabeculated with cords ofmuscular cardiac tissue traversing its surface with one or multiplelobes.

The atrial appendages appear to be inert while blood is being pumpedthrough them during normal heart function. In other words, theappendages don't appear to have a noticeable effect on blood pumpedthrough them during normal heart function. However, in cases of atrialfibrillation, when the atria go into arrhythmia, blood may pool andthrombose inside of the appendages. Among other things, this can pose astroke risk when it occurs in the left appendage since the thrombus maybe pumped out of the heart and into the cranial circulation once normalsinus rhythm is restored following arrhythmia events.

Historically, appendages have sometimes been modified surgically toreduce the risk imposed by atrial fibrillation. In recent years deviceswhich may be delivered percutaneously into the left atrial appendagehave been introduced. The basic function of these devices is to excludethe volume within the appendage with an implant which then allows bloodwithin the appendage to safely thrombose and then to be graduallyincorporated into cardiac tissue. This process, coupled with the growthof endothelium over the face of the device, can leave a smooth,endothelialized surface where the appendage is located. In comparison tosurgical procedures, devices implanted percutaneously are a lessinvasive means for addressing the problems associated with the leftatrial appendage.

However, due to the wide variability of the ostium size and volume ofthe left atrial appendage, current implantable devices conventionallyinclude a structure that cannot meet such variability, resulting ininadequate devices for many left atrial appendage anatomies. Further,such implantable devices are substantially limited by the orientation bywhich they can successfully be deployed. As such, it would beadvantageous to provide a percutaneous system, method and/or device thataddresses, for example, the issues of implant orientation, thevariability in sizes and shapes of the left atrial appendage, or all ofthese, in order to provide high success in left atrial appendagemodification. It would also be desirable to provide a device, system andmethod that enable easy positioning and repositioning of the devicerelative to the structure being modified or occluded including thepositioning (or repositioning) of an occluder portion independent ofother components or features of the device.

A variety of features and advantages will be apparent to those ofordinary skill in the art upon reading the description of variousembodiments set forth below.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to various devices,systems and methods of occluding an opening in the tissue of a body. Forexample, in one embodiment, a medical device is provided for modifying aleft atrial appendage (“LAA”) of a heart. The medical device includes anoccluder portion having a proximal end and a distal end. An anchorportion is operably coupled to the occluder portion. The anchor portionincludes multiple anchor segments each having a first end and a secondend, wherein the first and second ends are proximal the distal end ofthe occluder portion.

In accordance with another embodiment, a medical device is provided thatincludes an occluder portion including a plurality of occluder segmentscoupled to a primary hub and an anchor portion including a plurality ofanchor segments coupled to the primary hub and to an anchor hub. Theanchor hub is displaceable independent of, and relative to, the primaryhub to deploy the anchor segments from a retracted-anchor state to anexpanded-anchor state while the occluder portion remains in adeployed-occluder state. The anchor hub is positioned proximal theprimary hub when the anchor segments are in the retracted-anchor state.

In another embodiment, another medical device is provided for modifyinga left atrial appendage of a heart. The medical device includes anoccluder portion having a proximal end and a distal end. The proximalend is coupled to a hub and the occluder portion configured to movebetween an occluder-deployed state and an occluder-nondeployed state. Ananchor portion is operably coupled to the occluder portion. The anchorportion is configured to be moved between an anchor-deployed state andan anchor-nondeployed state. The distal end of the occluder portion islocated distal of a distal end of the anchor portion when the anchorportion is in the anchor-nondeployed state.

Another medical device is provided having at least one hub and anoccluder portion having a plurality of occluder frame segments. Theoccluder frame segments have a proximal end and a distal end with theproximal ends connected to the at least one hub. An anchor portion,having a plurality of anchor frame segments, is movable between aconstricted state and an expanded state. The anchor frame segments eachinclude a first end and a second end with an intermediate portiontherebetween. Each of the first ends are coupled to the at least one huband each of the second ends are coupled together. The second ends of theanchor frame segments are configured to move distally and proximallyrelative to the proximal end of the occluder frame segments so as tomove between the expanded state and the constricted state. The secondend of the anchor frame segments, while in the constricted state, areconfigured to be positioned proximal of the proximal end of the occluderframe segments.

In yet another embodiment, another medical device is provided formodifying a left atrial appendage of a heart. The medical deviceincludes an occluder portion coupled to a hub. The occluder portion isconfigured to move between an occluder-deployed state and anoccluder-nondeployed state. An anchor portion includes multiple anchorsegments configured to permanently engage tissue in the LAA. Each of theanchor segments have a first end and a second end, the first end beingcoupled to the hub. The anchor portion is configured to be moveablethrough the hub between an anchor-deployed state and ananchor-nondeployed state.

In accordance with another embodiment, yet another medical device isprovided for modifying a left atrial appendage. The medical deviceincludes an occluder portion coupled to a hub, the hub defining a boretherethrough. An anchor portion includes multiple anchor segmentsconfigured to permanently engage tissue in the LAA, wherein each of themultiple anchor segments are moveable through the bore of the hubbetween a retracted position and a deployed position.

In another embodiment, a medical device is provided that includes a huband an occluder portion having a plurality of occluder frame segments.The occluder frame segments include a proximal portion and a distal end,the proximal portion being connected to the hub. An anchor portion has aplurality of anchor frame segments that each include a first end and asecond end with an intermediate portion therebetween. Each of the firstends are coupled to the hub and the second ends are coupled togetherwith the intermediate portions being displaceable through the hub.

In accordance with a further embodiment, another medical device formodifying a left atrial appendage of a heart includes an occluderportion coupled to a hub, the hub defining a bore therethrough, and ananchor portion including multiple anchor segments. Each of the multipleanchor segments have a first end coupled with the hub. A portion of eachframe segment, other than the first end, extends through the bore of thehub.

Another embodiment of the a medical device for modifying a left atrialappendage includes an occluder portion coupled to a hub and an anchorportion operably coupled to the occluder portion. The anchor portion isconfigured to roll-inward to a retracted position and roll-outward to adeployed position.

In another embodiment, a medical device for modifying a left atrialappendage includes an occluder portion coupled to a hub and an anchorportion operably coupled to the occluder portion. The anchor portion isconfigured to be moved to a retracted position by at least partiallyinverting the anchor portion relative to the occluder portion. Theanchor portion is also configured to be moved to a deployed position byat least partially everting the anchor portion relative to the occluderportion.

In accordance with a further embodiment, a medical device for modifyinga left atrial appendage of a heart is provided and includes an occluderportion coupled to a hub. The occluder portion is moveable between anondeployed position and a deployed position. An anchor portion isoperably coupled to the occluder portion. The anchor portion includesmultiple anchor segments having engaging members oriented and configuredto engage tissue of the LAA when the anchor portion is in atissue-engaging position. The device also includes a plurality ofextensions, each extension being coupled to an associated anchor segmentand extending inward and proximally from a location adjacent theengaging members. Each extension is also configured to be pulledproximally to move the engaging members from the tissue-engagingposition to a tissue-nonengaging position while the occluder portion isin the deployed position.

Another embodiment of the present invention includes a medical devicefor modifying a left atrial appendage of a heart and includes anoccluder portion coupled to a hub and an anchor portion operably coupledto the occluder portion. The anchor portion includes multiple engagingmembers extending therefrom. The anchor portion is moveable between afully deployed state and a non-deployed state. The multiple engagingmembers are oriented to extend proximally from the anchor portion whenthe anchor portion is in the fully deployed state and the multipleengaging members oriented to extend distally form the anchor portionwhen the anchor portion is in the non-deployed state.

In accordance yet a further embodiment, a medical device is provided formodifying a left atrial appendage of a heart. The medical deviceincludes an occluder portion coupled to a hub and an anchor portionoperably coupled to the occluder portion. The anchor portion includesmultiple anchor segments, at least one anchor segment including alongitudinal length, a width and a depth. The longitudinal lengthextends along a curved portion between a first end and a second end ofthe at least one anchor segment. The depth is substantially constantalong the longitudinal length and the width varies along at least aportion of the longitudinal length.

In accordance with another embodiment, a medical device is provided formodifying a left atrial appendage of a heart. The medical deviceincludes an occluder portion extending from a hub and an anchor portionoperably coupled to the occluder portion. The anchor portion includesmultiple anchor segments, at least one anchor segment including alongitudinal length, a width and a depth, wherein the longitudinallength extends along a curved portion between a first end and a secondend of the at least one anchor segment. The at least one anchor segmenthas an aspect ratio of the depth to the width along at least a portionof the longitudinal length that is greater than 1 to 1. In someembodiments, the aspect ratio may be between approximately 1.1 to 1 andapproximately 5.7 to 1.

In a further embodiment, a medical device is provided for modifying aleft atrial appendage of a heart and includes a hub having an outersurface and an inner surface defining a bore therethrough. An occluderportion has multiple separate and discreet occluder frame segments,wherein the occluder frame segments are each separately and discreetlycoupled to the outer surface of the hub. Each occluder frame segment hasa generally planar configuration. An anchor portion includes multipleseparate and discreet anchor frame segments, wherein each of the anchorframe segments including a first end and a second end. The first ends ofeach of the anchor frame segments each are separately and discreetlycoupled to the outer surface of the hub in an alternating arrangementwith the occluder frame segments. The second ends of each of the anchorframe segments are coupled together. Each of the anchor frame segmentshas a generally planar configuration.

In yet another embodiment of the present invention, a medical device isprovided for modifying a left atrial appendage of a heart. The medicaldevice includes one or more hubs having an outer surface and an innersurface defining a bore therethrough. An occluder portion includesmultiple separate and discreet occluder frame segments, wherein theoccluder frame segments are each separately and discreetly coupled tothe one or more hubs. Each occluder frame segment has a generally planarconfiguration. An anchor portion includes multiple separate and discreetanchor frame segments, wherein each of the anchor frame segments includea first end and a second end. Each of the first ends of the anchor framesegments are separately and discreetly coupled to the one or more hubs.Each of the second ends of the anchor frame segments are coupledtogether. Each of the anchor frame segments has a generally planarconfiguration.

In a further embodiment, a method is provided of modifying a left atrialappendage of a heart. The method includes advancing a medical devicewith a catheter of a delivery system through the vasculature and intothe left atrial appendage of the heart, wherein the medical deviceincludes an occluder portion coupled to a hub and an anchor portionoperably coupled to the occluder portion. The occluder portion isdeployed from the delivery system within the LAA and the deployedoccluder portion is moved within the LAA. A preferred position of thedeployed occluder portion within the LAA is confirmed. The anchorportion is moved between a retracted position and a deployed positionsubsequent to confirming the preferred position of the deployed occluderportion. Tissue within the LAA is engaged with the anchor portion toanchor or secure the occluder portion in the preferred position withinthe LAA.

In yet another embodiment, a medical device delivery system is provided.The system includes a medical device having an occluder portion and ananchor portion. A catheter includes tethers extending therethrough, thetethers being releaseably coupled to the medical device. A handle systemis coupled to the catheter and coupled to the tethers. The handle systemincludes a mode switch that is movable between a first position and asecond position. The mode switch includes one or more key holes, whereinthe one or more key holes, while the mode switch is in the firstposition, are configured to allow actuation of the anchor portion of themedical device and wherein the one or more key holes, while the modeswitch is in the second position, are configured to prevent actuation ofthe anchor portion of the medical device.

In accordance with another embodiment, a medical device delivery systemis provided. The system includes a medical device having an occluderportion and an anchor portion. A catheter includes an occluder tetherand an anchor tether extending therethrough, wherein the occluder tetheris releaseably coupled to the occluder portion and the anchor tether isreleasably coupled to the anchor portion. A handle system is coupled tothe catheter, wherein the handle system includes an occluder handleportion coupled to the occluder tether, an anchor handle portion coupledto the anchor tether and a mode switch movable between a first positionand a second position. The mode switch, when in the first position, isconfigured to independently move the anchor portion between a deployedposition and a retracted position while the occluder portion remains ina deployed state. Additionally, when the mode switch is in the secondposition it is configured to prevent movement of the anchor portion ofthe medical device.

In accordance with yet another embodiment, a medical device is providedfor modifying a left atrial appendage of a heart. The medical deviceincludes a hub an occluder portion coupled to the hub. The hub isconfigured to be moved between an occluder-nondeployed position and anoccluder-deployed position. An anchor portion is operably coupled to theoccluder portion and configured to be moved, independent of movement ofthe occluder portion, between an anchor-nondeployed position and ananchor-deployed position while the occluder portion is in theoccluder-deployed position. The medical device is configured to bemoveable throughout the LAA while the occluder portion is in theoccluder-deployed position and the anchor portion is in theanchor-nondeployed position, to multiple different positions within theLAA, to determine a preferred position for selective anchoring of theoccluder portion at the preferred position within the LAA.

These various embodiments may include other components, features or actsas will be apparent from the detailed description set forth below.Additionally, other embodiments, configurations and processes are setforth below in the detailed description of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing and other advantages of the invention will become apparentupon reading the following detailed description and upon reference tothe drawings in which:

FIG. 1 is a side view of a medical device delivery system, according toan embodiment of the present invention;

FIG. 1A is a side view of a medical device employed with the medicaldevice delivery system of FIG. 1, depicting the device being implantedin a left atrial appendage, according to an embodiment of the presentinvention;

FIG. 2 is a perspective view of the medical device of FIG. 1A, depictingthe medical device in a fully expanded position, according to anembodiment of the present invention;

FIG. 3 is a side view of the medical device of FIG. 2;

FIG. 3A is a cross-sectional view of the medical device of FIG. 3;

FIG. 3B is an enlarged view of a hub system of FIG. 3A;

FIGS. 4A through 4D are side views of the medical device of FIGS. 2 and3, depicting various stages of deploying the medical device from themedical device delivery system in a left atrial appendage of the heart,according to an embodiment of the present invention;

FIG. 5A is a side view of an occluder frame segment of the medicaldevice, according to an embodiment of the present invention;

FIG. 5B is a side view of the occluder frame segment of FIG. 5A coupledto a ring system, according to another embodiment of the presentinvention;

FIG. 5C is a perspective view of an occluder frame, according to anembodiment of the present invention;

FIGS. 6A and 6B are side views of anchor frame segments of an anchorsystem, according to an embodiment of the present invention;

FIG. 6C is a perspective view of an anchor system using the framesegments shown in FIGS. 6A and 6B, according to an embodiment of thepresent invention;

FIGS. 7A and 7B are side views of anchor frame segments and occluderframe segments, respectively, according to another embodiment of thepresent invention;

FIG. 7C is a perspective view of a frame of a medical device, depictingmultiple anchor frame segments and occluder frame segments shown inFIGS. 7A and 7B, respectively, according to an embodiment of the presentinvention;

FIG. 8 is a cross-sectional view of the medical device of FIG. 7C;

FIG. 8A is an enlarged cross-sectional view of the hub system of themedical device of FIG. 8 also depicting a distal portion of the deliverysystem, according to an embodiment of the present invention;

FIGS. 9A and 9B are distal and proximal perspective views of a medicaldevice, according to another embodiment of the present invention;

FIG. 10A is a side view of an occluder frame segment of the medicaldevice shown in FIGS. 9A and 9B, according to the present invention;

FIG. 10B is a side view of the occluder frame segment, depicting aportion of a tissue growth member attached to the occluder framesegment, according to the present invention;

FIGS. 11A through 11C are side views of anchor frame segments of themedical device shown in FIGS. 9A and 9B, according to the presentinvention;

FIG. 12A is an enlarged view of detail “12A” taken from FIG. 11A,depicting engaging members extending from the anchor frame segments,according to one embodiment of the present invention;

FIG. 12B is another embodiment of an anchor frame segment, depicting awire wrapped around the anchor frame segment, according to an embodimentof the present invention;

FIG. 13 is a perspective view of an anchor hub system, according to anembodiment of the present invention;

FIGS. 14A and 14B are cross-sectional side views of respective anchorframe segments and occluder frame segments interconnected to a hubsystem of a medical device according to one embodiment of the presentinvention;

FIG. 15 is an end view of a ring utilized in the hub system of FIG. 14A,according to one embodiment of the present invention;

FIG. 16 is a perspective side view of the medical device (without atissue growth member) of FIGS. 9A and 9B, according to the presentinvention;

FIGS. 17A and 17B are proximal and distal perspective views of a medicaldevice, according to another embodiment of the present invention;

FIGS. 18A and 18B are proximal and distal perspective views of a medicaldevice depicting multiple tissue growth members and layers, according toan embodiment of the present invention;

FIG. 19 is a cross-sectional view of a portion of the medical device,depicting an anchor hub with a hub tissue growth member attachedthereto, according to an embodiment of the present invention;

FIG. 20 is a side view of a single anchor segment of the anchoringsystem, depicting a dissolving member providing support to anchorportions of the anchor segment, according to one embodiment of thepresent invention;

FIG. 20A is an enlarged view of the dissolving member coupled to theanchor segment of FIG. 20, according to an embodiment of the presentinvention;

FIG. 21 is a perspective view of a medical device coupled to medicaldevice delivery system, depicting a handle system in a first handleposition, according to one embodiment of the present invention;

FIG. 21A is partial perspective view of the medical device and medicaldevice delivery system of FIG. 21, depicting the medical device with ananchor portion deployed when the handle system is in a second handleposition, according to an embodiment of the present invention;

FIG. 21B is a partial perspective view of the medical device and medicaldevice delivery system of FIG. 21, depicting the medical device withtethers deployed when the handle system is in a third handle position,according to an embodiment of the present invention;

FIG. 21C is an enlarged cross-sectional view of the catheter system,taken along line 21C of FIG. 21, according to another embodiment of thepresent invention;

FIG. 22 is a proximal end view of the handle system of FIG. 21,according to an embodiment of the present invention;

FIG. 23 is a cross-sectional side view of the handle system, taken alongline 23 of FIG. 22, depicting the handle system in the first handleposition, according to an embodiment of the present invention;

FIG. 23A is a cross-sectional view of the handle system, taken alongline 23A of FIG. 23, depicting a mode switch of the handle system,according to an embodiment of the present invention;

FIG. 24 is a cross-sectional bottom view of the handle system, takenalong line 24 of FIG. 22, depicting the handle system in the firsthandle position, according to an embodiment of the present invention;

FIG. 24A is an enlarged section view of a float handle portion of thehandle system, taken from detail “24A” of FIG. 24, according to anembodiment of the present invention;

FIG. 24B is an enlarged section view of a occluder handle portion of thehandle system, taken from detail “24B” of FIG. 24, according to anembodiment of the present invention;

FIG. 24C is an enlarged section view of an anchor handle portion of thehandle system, taken from detail “24C” of FIG. 24, according to anembodiment of the present invention;

FIG. 25 is a cross-sectional side view of the handle system, depictingthe handle system in the second handle position, according to anotherembodiment of the present invention;

FIG. 25A is a cross-sectional view of the handle system, taken alongsection line “25A” of FIG. 25, according to an embodiment of the presentinvention;

FIG. 26 is a cross-sectional side view of the handle system, depictingthe handle system in the third handle position, according to anembodiment of the present invention;

FIG. 26A is a cross-sectional view of the handle system, taken alongsection line “26A” of FIG. 26, according to an embodiment of the presentinvention;

FIG. 27 is a proximal end view of the handle system, depicting arelease-enable switch in a released position, according to an embodimentof the present invention;

FIG. 28 is a cross-sectional side view of the handle system, taken alongsection line “28” of FIG. 27, depicting the handle system in thereleased position;

FIG. 28A is a cross-sectional view of the handle system, taken alongsection line “28A” of FIG. 28;

FIG. 29 is a cross-sectional bottom view of the handle system, takenalong section line “29” of FIG. 27, depicting the handle system in thereleased position;

FIG. 30 is an enlarged cross-sectional side view of a proximal endportion of the handle system, taken along section line “30” of FIG. 22,depicting the end portion of the handle system before the releasedposition;

FIG. 31 is an enlarged perspective view of the proximal end portion ofthe handle system, depicting the handle system before the releasedposition and without an outer housing of the handle system shown;

FIG. 32 is an enlarged cross-sectional side view of a proximal endportion of the handle system, taken along section line “32” of FIG. 27,depicting the handle system in the released position and without anouter housing of the handle system shown;

FIG. 33 is an enlarged perspective view of a proximal portion of anchorhandle portion of the handle system, depicting the handle system in thereleased position and without an outer housing of the anchor handleportion shown;

FIG. 34 is an enlarged perspective view of the occluder handle portionof the handle system (without showing the handle outer housing forpurposes of clarity and convenience), depicting the occluder handleportion in the non-released position;

FIG. 34A is an enlarged perspective view of a portion of anoccluder-release slider and release rod, taken from detail “34A” of FIG.34;

FIG. 34B is an enlarged perspective view of a portion of a release rod,taken from detail “34B” of FIG. 34;

FIG. 35 is an enlarged perspective view of the occluder-release sliderand release rod (without showing the handle outer housing for purposesof clarity and convenience), depicting the occluder-release slider andrelease rod in the released position;

FIG. 35A is an enlarged perspective view of a release rod and a pawl ofthe occluder-release slider, taken from detail “35A” of FIG. 35,according to an embodiment of the present invention;

FIG. 36 is an enlarged cross-sectional view of a medical device beingpushed through a sheath by a catheter system, according to an embodimentof the present invention;

FIG. 37 is an enlarged cross-sectional view of an occluder portion ofthe medical device being deployed from the sheath, according to anembodiment of the present invention;

FIG. 38 is an enlarged cross-sectional view of an anchor portion withthe occluder portion of the medical device deployed from the cathetersystem, according to an embodiment of the present invention;

FIG. 38A is an enlarged cross-sectional view of the catheter system andsheath, taken from line 38A, according to an embodiment of the presentinvention;

FIG. 39 is an enlarged cross-sectional view of an interconnectionbetween the medical device and tether wires, according to an embodimentof the present invention;

FIG. 40 is an enlarged cross-sectional view of the medical device andtethers deployed from the catheter system, according to an embodiment ofthe present invention;

FIG. 41 is a partial perspective view of an articulating catheter,depicting a distal portion of the catheter, according to an embodimentof the present invention;

FIG. 41A is an enlarged perspective view of the distal portion of thearticulating catheter, taken from section 41A of FIG. 41, according toan embodiment of the present invention;

FIG. 42 is a side view of an articulating handle system, according to anembodiment of the present invention;

FIG. 42A is an enlarged cross-sectional view of the articulating handlesystem, taken from line 42A of FIG. 42, according to an embodiment ofthe present invention;

FIG. 43 is a perspective view of a flexure member, according to anembodiment of the present invention;

FIG. 44 is a cross-sectional view of a wire engaging member, taken fromline 44 of FIG. 42, according to an embodiment of the present invention;

FIG. 45 is a partial cross-sectional view of a medical device accordingto another embodiment of the present invention;

FIG. 46 is a partial cross-sectional view of a medical device accordingto yet another embodiment of the present invention; and

FIG. 47 is a partial cross-sectional view of a medical device accordingto yet a further embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1 and 1A, a medical device system 10 is disclosedthat may be used to occlude or modify an opening or cavity 5 such as,for example, a left atrial appendage (LAA). In one embodiment, themedical device system 10 may include a handle 12 with one or moreactuators and a fluid port 14. In addition, the system 10 may include acatheter 16 with a catheter lumen extending longitudinally therethroughand attached to a distal end of the handle 12. Such a catheter lumen maycoincide and communicate with a handle lumen as well as communicate withthe fluid port 14.

The actuators associated with the handle may be configured to actuate ormove a medical device 40 disposed within a distal portion 20 of thecatheter 16 to deploy the medical device 40 from or within the distalportion 20 of the catheter 16, to capture (or recapture) the medicaldevice 40 within the distal portion 20 of the catheter, or to do both.Such a medical device 40 can be interconnected to the handle 12 viatethers coils or other structures or elements (generally referred to astethers herein for convenience) extending through the catheter 16(tethers not shown in FIGS. 1 and 1A). For example, the tethers can havea proximal end connected to the handle 12 and a distal end thereofconnected to the medical device 40. The medical device 40 can bemanipulated to be deployed and recaptured at different stages bycontrolling movement of the tether/coils (via the actuators) andcontrolling movement of the catheter 16.

The medical device 40, shown in deployed position in FIG. 1A (whereinthe device is fully or at least substantially expanded), may include anoccluder system 42 and an anchor system 44. As briefly noted above, themedical device 40 can be controlled to deploy in discrete stages withone stage being the deployment of the occluder system 42 and another,discrete stage being deployment of the anchor system 44. In this manner,a physician can first deploy the occluder system 42, locate a preferableposition and orientation for the occluder system 42 in the LAA 5 and,once positioned and oriented satisfactorily, the physician can maintainsuch position while independently deploying the anchor system 44. Assuch, the occluder system 42 and the anchor system 44 are configured tobe deployed independent of one another as discrete, affirmative acts bya physician or operator of the system 10.

As previously noted, the handle 12 may include multiple actuatorsincluding a release mechanism 32. The release mechanism 32 is configuredto release the medical device 40 from the tethers once the medicaldevice 40 is anchored in the LAA 5 as will be described in furtherdetail below. Other actuators may include a first actuator 22, a secondactuator 24, a third actuator 26, a fourth actuator 28 and a fifthactuator 30 as shown in FIG. 1. For example, the first actuator 22 andthe second actuator 24 may be configured to control movement of theoccluder system 42 while the third actuator 26 and the fourth actuator28 may be configured to control movement of the anchor system 44. Thefifth actuator 30 may be configured to control maneuverability of thedistal portion 20 of the catheter 16 to negotiate tight corners andfacilitate orientation when placing the medical device 40 in the LAA 5.It should be noted that, for example, the first actuator 22 and thesecond actuator 24 can be configured as, or to act as, a single actuatorfor the occluder system 42. Likewise, the third actuator 26 and thefourth actuator 28 can be configured as, or to act as, a single actuatorfor the anchor system 44.

With reference to FIGS. 2, 3 and 3A, the occluder system 42 may includean occluder frame 43 coupled to an occluder hub system 46 and a tissuegrowth member 48. The occluder frame 43 includes multiple occluder framesegments 50 extending radially and distally from the occluder hub system46 generally in a spoke-like configuration. Such an occluder frame 43 isconfigured to assist in both expanding the tissue growth member 48 andin collapsing the tissue growth member 48. As such, each frame segment50 may include an expander portion 52 and a collapser portion 54,wherein the expander portion 52 can include an overall length greaterthan that of the collapser portion 54. For example, each expanderportion 52 may extend further radially, further distally, or both, ascompared to a collapser portion 54.

Further, each frame segment 50 may include a clip 56 on each of theexpander portion 52 and collapser portion 54. The clips 56 may beutilized to attach the tissue growth member 48 between the expanderportion 52 and the collapser portion 54. Such clips 56 are each shown inan open position (FIG. 3A), but when attaching the tissue growth member48 to the occluder frame 43, the clips 56 are moved to a closedposition, as indicated by arrow 58. In this manner, the tissue growthmember 48 can be readily attached to the occluder frame 43.

The tissue growth member 48 may include a porous structure configured toinduce or promote tissue in-growth, or any other suitable structureconfigured to promote tissue in-growth. The tissue growth member 48 caninclude, for example, a body or a structure exhibiting a cup-like shapehaving an outer surface 60 and an inner surface 62. The outer surface 60may include a distal surface portion 64 and a proximal surface portion66. The outer surface distal surface portion 64 of the tissue growthmember 48 can be sized and configured to be in direct contact with atissue wall 7 within the LAA 5 (see FIG. 1A). In one embodiment, thetissue growth member 48 may be configured to self expand from a confinedor constricted configuration to an expanded or deployed configuration.In one embodiment, the tissue growth member 48 may include a polymericmaterial, such as polyurethane foam. Other materials with desiredporosity can also be used, such as felt, fabric, Dacron®, Nitinol bradedwire, or polymeric or Nitinol felt. In the case of foam, such foam maybe a reticulated foam, typically undergoing a chemical or heatingprocess to open the pores within the foam as known by those of ordinaryskill in the art. The foam may also be a non-reticulated foam. In oneembodiment, the foam may include graded density or a graded porosity, asdesired, and manipulated to expand in a desired shape when the framemember is moved to the expanded configuration.

In another embodiment, the tissue growth member 48 may includepolyurethane foam with a skin structure on the inner surface 62, on theouter surface 60, or on both surfaces. For example, a skin structure maybe formed on the inner surface 62 and be configured to inhibit bloodfrom flowing through the tissue growth member 48, while the outersurface 60 of the tissue growth member may be configured to receiveblood cells within its pores and induce tissue in-growth. In oneembodiment, such a skin structure can include a layer of material, suchas tantalum, sputtered to a surface of the tissue growth member 48. Inanother embodiment, the skin structure can include a polyurethane foamskin. Another example includes attaching expandedpolytetrafluoroethylene (ePTFE) to the outer surface 60 or inner surface62 of the tissue growth member 48, the ePTFE having minimal porosity tosubstantially inhibit blood flow while still allowing endothealizationthereto.

In one embodiment, the anchor system 44 may include a plurality ofanchor components and an anchor hub system 70. The anchor hub system 70may be configured to be positioned and disposed within or adjacent tothe occluder hub system 46. The plurality of anchor components caninclude, for example, a first anchor component 72 and a second anchorcomponent 74. Each of the first anchor component 72 and the secondanchor component 74 may include a pedal or loop configuration (shown inFIGS. 2, 3, 3A, 6A and 6B in an expanded configuration), with, forexample, two loop configurations for each of the first and second anchorcomponents 72 and 74, that are interconnected together via the anchorhub system 70 (discussed in more detail below). Each loop may besubstantially oriented orthogonally with respect to an adjacent loop(i.e., in the embodiment shown in FIGS. 2 and 3, each loop of anchorcomponent 72 being orthogonal to adjacent loops of anchor component 74).It is noted that, as used herein, the term “loop” does not require thata closed curve be formed of the component, but rather that asubstantially closed curved or an open curve having a portion of thecurve return on itself may also be considered as a “loop.”

While in the expanded configuration, each loop may extend distally ofthe occluder system 42 and radially outward to a larger configurationthan the anchor hub system 70. In other words, at least a portion of theanchor components 72 and 74 extend distally beyond the distal-mostportion of the occluder system 42 and radially beyond the radial-mostportion of the occluder system as taken from a longitudinal axis 75extending through the hub system 70. Each loop of an anchor component 72and 74 may also include engagement members or traction nubs 78 on anouter periphery of a loop configuration, the traction nubs 78 beingsized and configured to engage and grab a tissue wall 7 within the LAA 5(see FIG. 1A). In one embodiment, the traction nubs 78 may be configuredto aggressively engage the tissue wall 7 without piercing or penetratingthe tissue. As such, such traction nubs may be configured as atraumaticstructures.

Each of the loop configurations of the first anchor component 72, whilein an expanded configuration, are substantially co-planar with eachother and in a substantially flat configuration. Likewise, each of theloop configurations of the second anchor component 74, while in anexpanded configuration, are substantially co-planar with each other andin a substantially flat configuration. In one embodiment, the firstanchor component 72 may be attached to the second anchor component 74such that the loop configuration between the first and second anchorcomponents 72 and 74 are oriented substantially orthogonal with respectto each other. In other words, the plane in which the first anchorcomponent 72 is positioned or oriented is substantially orthogonal withrespect to the plane of the second anchor component 74. In otherembodiments, there may be more than two anchor components, in which casesuch anchor components may or may not be oriented in a substantiallyorthogonal manner relative to each other.

With reference to FIGS. 3A and 3B, the medical device system 10 includesmultiple catheters or tubular members and tether systems to manipulatemovement and deployment of the occluder system 42 as well as the anchorsystem 44. For example, the primary catheter 16 or outer catheter mayinclude a first tubular member 80 and a second tubular member 82positioned therein and extending substantially the longitudinal lengththereof. Such tubular members can be catheter components, coiledcomponents or any other suitable tubular member known in the art.Further, as previously noted, the medical device system 10 may include afirst tether system 84 and a second tether system 86, the first tethersystem 84 configured to be tethered to the occluder system 42 and thesecond tether system 86 configured to be tethered to the anchor system44. The tether systems 84 and 86 may include, for example, one or morewires extending through a coiled component. In one embodiment,heat-shrink polymeric material may also be formed over the coiledcomponent.

As previously noted, the occluder system 42 may include, multipleoccluder frame segments 50, an occluder hub system 46 and a tissuegrowth member 48. Each occluder frame segment 50 may include a baseportion 90, an expander portion 52 and a collapser portion 54. The baseportion 90 may include a distal base portion 92 and a proximal baseportion 94. The proximal base portion 94 may include an attachment pointsuch as, for example, a tether eyelet 98. Further, the expander portion52 and the collapser portion 54 may extend radially from the proximalbase portion 94 of each occluder frame segment 50 and may also extenddistally from the proximal base portion 94 of each occluder framesegment.

The distal base portion 92 may include notches 96 sized and configuredto receive rings to form the occluder hub system 46. In one embodiment,the rings may include, for example, two outer rings 100 and one or moreintermediate inner rings 102, each positioned and interconnected witheach base portion of the occluder frame segments 50 to form the occluderhub system 46. With this arrangement, the occluder system 42 may bedeployed from the primary catheter 16 with the first tether system 84having a portion thereof attached to the tether eyelet 98 at theproximal base portion 94. Although not shown in FIG. 3B, deployment ofthe occluder system 42 can be effected while the anchor system 44 isstill retracted within the first tubular member 80 so that only theoccluder system 42 is deployed. The occluder system 42 may also beretracted back into the distal portion 20 of the primary catheter 16 ifdesired, for example, to enable repositioning of the occluder system 42within the LAA 5. In this manner, a physician can deploy the occludersystem 42 at a desired location and orientation within the LAA 5 whilealso maintaining access to the occluder system 42 via the firsttethering system 84.

The anchor system 44, as previously indicated, may include an anchor hubsystem 70, a first anchor segment 72 and a second anchor segment 74,with each anchor segment 72 and 74 including two loop configurationswhen in an expanded configuration. Each of the loops may include a firstend portion 104 and a second end portion 106 with an intermediateportion 108 therebetween. The intermediate portion 108 includes theengagement nubs or traction nubs 78, such as previously set forth. Whenthe anchor system 44 is in a deployed state, the first end portion 104of the loop can extend from a base portion 112 and the second endportion 106 can interlock with the anchor hub system 70 includingmultiple rings 110 disposed within or adjacent to the occluder hubsystem 46. The first end portion 104 of each loop of the first anchorsegment 72 can each extend from the base portion 112 thereof. Likewise,the first end portion 104 of each loop of the second anchor segment 74can each extend from the base portion 112 of the second anchor segment74.

The base portion 112 of each of the first and second anchor segments 72and 74 can be interlocked or coupled together and configured to bepositioned within or adjacent to the rings 110 (when in the deployedconfiguration) and moveable to a proximal position within the firsttubular member 80 toward a retracted or un-deployed position. Such baseportion 112 is configured to be tethered to the second tethering system86 via an eyelet 114 or other structure in the base portion 112.Further, the base portion 112 can be moved within the first tubularmember 80 between a retracted position and a deployed position. In theretracted position, the base portion 112 is positioned proximally in thefirst tubular member 80, in which a substantial portion of each of thefirst and second anchor segments 72 and 74 are rolled within the firsttubular member 80 such that the “loop” portion of the anchor segments 72and 74 exhibit a relatively tighter curve or smaller radius. Further, inthe retracted position, the anchor hub system 70 can also be movedproximal the occluder hub system 46 because both systems can actindependent of each other. When moving the anchor system 44 to thedeployed position, the anchor hub system 70 may be moved distally toengage or abut a portion of the occluder hub system 46 via a stopper 116defined on the second end portion 106 of the anchor segments 72 and 74,after which, the base portion 112 of anchor segments 72 and 74 can bemoved distally with respect to the first tubular member 80 or primarycatheter, from which the anchoring system 44 rolls out of the primarycatheter 16 to expand the loops into the deployed position. In anotherembodiment, the second end portion of anchor segments 72 and 74 mayremain adjacent to the occluder hub system in both the deployed andretracted states while the base portion is displaced relative to theoccluder hub system 46 for deployment of the anchor system 44. In eitherconfiguration, the physician maintains access and control of theanchoring system 44 via the second tethering system 86 and can,therefore, determine if the medical device 40 is properly placed or, ifnot, can readily retract the anchor system 44 by moving the base portion112 of the anchor segments proximally to roll a substantial portion ofthe anchor segments 72 and 74 within the first tubular member 80.

With respect to FIGS. 4A through 4D, the medical device 40 is shownwhile being deployed in an LAA 5, primarily employing a two stagedeployment method, in which an occluder system 42 is deployed and thenan anchoring system 44 is deployed. With reference to FIG. 4A, thedistal portion 20 of the catheter 16 of the medical device system 10 isadvanced to the LAA 5. As shown by dashed lines, the distal portion 20may be manipulated and maneuvered to make sharp turns as needed in orderto access the LAA 5 or an area adjacent thereto. This can be employed,for example, by actuation of the fifth actuator 30 (FIG. 1) which may beconfigured to properly orient and obtain favorable initial position ofthe distal portion 20 of the catheter 16. For example, the fifthactuator 30 may be coupled to a line 120 that is, in turn, coupled to afixed point or block 122 that is distal of a region 124 in which a bendwould be desired within the distal portion 20 of the catheter 16. In oneembodiment, the material at the bend region 124 of the primary catheter16 can be softened or thinned so that when the line 120 is pulled viathe fifth actuator 30, the primary catheter 16 will bend at the regionof softened or thinned material. This can also be accomplished via apull line and/or a push line, the push line having, for example, a coilemployed therewith.

With respect to FIG. 4B, the occluder system 42 is shown being deployedfrom the distal portion 20 of the medical device delivery system 10(though the anchor system 44 is not yet deployed). Before deploying theoccluder system 42, the physician may initially manipulate the distalportion 20 of the delivery system 10 distal of the ostium 9 of the LAA5. Once in a favorable position, the physician can deploy the occludersystem 42 and then move the occluder system proximally within the LAA 5until a desired orientation and position of the occluder system 42 isobtained in the LAA 5. With reference to FIG. 3B, the occluder system 42can be deployed, for example, by maintaining position of the occludersystem 42 via the first tethering system 84 and retracting the primarycatheter 16 relative to the occluder system 42. The occluder frame,which may be formed of, for example, a shape memory material asdiscussed in further detail below, can then self expand as it isunsheathed from the primary catheter 16. In this manner, the distalsurface portion 64 of the outer surface 60 of the tissue growth member48 is radially expanded to come in contact with the tissue wall 7 of theLAA 5.

With respect to FIG. 4C, once the physician obtains a desired positionin the LAA 5, (which may be at a position and orientation other thanthat shown), the physician can then begin to deploy the anchor system 44while holding the position of the occluder system 42 in the LAA 5. Withthe occluder system 42 maintaining the selected position in the LAA 5,the anchor system 44 can begin to be deployed by moving the anchor hubsystem 70 relative to the occluder hub system 46 and pushing the baseportion 112 of the anchor system 44 distally via the second tetheringsystem 86 to, thereby, roll the anchor segments 72 and 74 out of theprimary catheter 16 or first tubular member 80 into the expanded loopconfigurations (see FIG. 3B).

Once the base portions 112 of the first and second anchor segments 72and 74 are moved to a fully distal position, i.e., adjacent the anchorhub system 70, the anchor system 44 is then fully deployed, as depictedin FIGS. 3, 3A and 4D. In this position, the primary catheter 16 andfirst and second tubular members 80 and 82 can be retracted and only thefirst and second tethering systems 84 and 86 maintain connection with oraccess to the respective occluder system 42 and anchor system 44. If thephysician is satisfied with the orientation and position of the medicaldevice 40 in the LAA, the medical device 40 can then be released via therelease mechanism 32 (FIG. 1). However, if the physician is notsatisfied, the anchoring system 44 and the occluder system 42 can thenbe respectively re-sheathed in the distal portion 20 of the catheter 16.The physician can then undergo another attempt using the same medicaldevice 40 and delivery system 10 again following the process describedabove. It is noted that the physician may use various imaging techniquesto monitor the placement and deployment of the medical device 40. Forexample, a physician may advance contrast in the LAA to view theposition of the medical device 40 via imaging techniques known in theart.

Referring now to FIGS. 5A through 5C, various components of the occludersystem 42 are shown in FIGS. 5A and 5B, while the assembly of theoccluder system 42 is shown in FIG. 5C according to an embodiment of thepresent invention. With respect to FIG. 5A, one occluder frame segment50 is shown including each of the base portion 90, expander portion 52and collapser portion 54. The occluder system 42 may include, forexample, four frame segments, but may include more or fewer than four inother embodiments. In one particular embodiment, eight frame segments 50may be employed. Each frame segment 50 may be, for example, laser cutfrom a sheet of Nitinol with the shape and design of the preferred fullyexpanded position as shown, for example, in FIG. 5A. In such anembodiment, each frame segment may be formed as a substantially planarmember or, stated otherwise, exhibit a substantially planarconfiguration. As depicted in FIGS. 5B and 5C, each occluder framesegment 50 is assembled in a ring or hub assembly 46 which may include,for example, two outer rings 100 and one inner ring 102. The rings 100and 102 may include notches (not shown in FIG. 5B or 5C) to orient andposition each of the occluder frame segments 50 at desired radialpositions along an inner and/or outer periphery of the rings.

For simplification purposes, only one frame segment is shown incross-section with the ring assembly in FIG. 5B, however, as shown inFIG. 5C, the occluder system 42 can include multiple frame segments 50positioned radially about the rings 100 and 102 in a desired pattern orgeometric configuration. The combination of the multiple base portions90 of each occluder frame segment 50 and the rings 100 and 102 form theoccluder hub system 46. Further, the occluder hub system 46 is sized andconfigured to facilitate at least a portion of the anchor system (notshown in FIGS. 5A-5C) through an opening (e.g., through the rings) ofthe occluder hub system 46. With this arrangement, each component of theoccluder system 42 can be laser cut from sheet of shape memory alloy(e.g., a nickel-titanium alloy, also know as Nitinol) if desired,including the rings 100 and 102. In other embodiments, the variouscomponents of the hub system can be formed employing polymers or othermetallic materials and machined using typical techniques and methods.Additionally, not all of the components need be formed from the samematerial or using the same manufacturing process. For example, in oneembodiment, the frame segments 50 may be formed by laser cutting themfrom Nitinol sheets as noted above, while the rings 100 and 102 areformed of a polymer material through a molding process.

Turning now to FIGS. 6A through 6C, the components of the anchor framesegments of the anchoring system 44 are shown. The first anchor segment72 (FIG. 6A) and the second anchor segment 74 (FIG. 6B) each include afirst end portion 104 and a second end portion 106, the first endportion 104 extending from the base portion 112 with an intermediateportion 108 between the first end portion 104 and the second end portion106. When in the expanded position (as shown in FIGS. 6A and 6B), eachanchor segment 72 and 74 can define one or more loop configurations. Forexample, the embodiment shown in FIGS. 6A and 6B each include two loops.

The base portion 112 of the first anchor segment 72 includes an openingor hole 118 extending therethrough. The hole 118 is sized and configuredto receive inner edge portions 120 of the second anchor segment 74. Withthis arrangement, the first anchor segment 72 is oriented and positionedin an orthogonal orientation with respect to the second anchor segment74 (see FIG. 6C) such that inner edge portions 120 of the second anchorsegment 74 engage the hole 118 of the first anchor segment 72.

It is also noted that the first end portion 104 tapers in thicknessalong its length extending toward the second end portion 106, or atleast partially along the curvilinear length thereof. Such taperprovides the resilience and expansion characteristics to maintain ananchored position (i.e., the deployed position of the anchor segments 72and 74). Further, the second end portion 106 includes a notchedconfiguration sized and configured to receive the rings 110 to form theanchor hub system 70. As previously set forth, the anchor hub system 70is sized and configured to be positioned within or adjacent to theoccluder hub system (not shown in FIGS. 6A-6C) when fully deployed. Thebase portion 112 of the second anchor segment 74 is further sized andconfigured to receive a ring member 122 around its proximal end. As withthe occluder system 40, the anchor segments 72 and 74 and the rings 110may be laser cut from a sheet of Nitinol material in the shape of theintended fully expanded configuration. In such an embodiment, each framesegment 72 and 74 may be formed as a substantially planar member or,stated otherwise, exhibit a substantially planar configuration. In thismanner, the anchor system 44 can be made and assembled. Of course, thecomponents of the anchor system 44 may be formed of other materials,using other manufacturing processes, as has been discussed previouslywith respect to the occluder system 40.

Referring now to FIGS. 7A, 7B, 7C, 8 and 8A, another embodiment of amedical device used for occluding an opening, such as an LAA, is shown.This embodiment is similar to the previously described embodiment,except in this embodiment, anchor segments are extensions of a baseportion of occluder frame segments. In other words, anchor framesegments and occluder frame segments are integral with one another,although independent deployment and retraction of the occluder systemand the anchor system is retained.

With initial reference to FIG. 7A, a frame segment 210 is shown thatincludes both an anchor segment 212 and occluder segment 214 that areintegral with one another. The anchor segment 212 and the occludersegment 214 are unitary or monolithic and, for example, may be laser cutas a single frame segment from a sheet of desired material such as, forexample, a Nitinol material. The anchor segment 212 includes a first endportion 222, a second end portion 224 and an intermediate portion 226therebetween. The first end portion 222 extends from an anchor base 228and tapers in thickness as it extends toward the second end portion 224at least partially along a curvilinear length thereof. The intermediateportion 226 may include engagement or traction nubs 234 configured toengage (but not necessarily pierce) the tissue wall of an LAA, when inan expanded, deployed configuration. The second end portion 224 extendsfrom a distal end 232 of a base portion 220 of the occluder segment 214.

An expander portion 216 and a collapser portion 218 both extend distallyand radially outward from a proximal end 236 of the base portion 220 ofthe occluder segment 214. The expander portion 216 may extend further,both distally and radially, than its associated collapser portion 218.As in the previous embodiment, the expander portion 216 and thecollapser portion 218 are configured to receive a tissue growth member(not shown in FIG. 7A-7C, 8 or 8A) therebetween. Further, the baseportion 220 includes notches 230 sized and configured to receive ringsto couple the multiple frame components, as described hereafter.

With respect to FIG. 7B, a discrete occluder frame segment 240 is shown.This discrete occluder frame segment 240 may be configured generallysimilar to the occluder segment 214 of FIG. 7A (as well as the occluderframe segments 50 of the previous embodiment), except this discreteoccluder frame segment 240 does not include the anchor frame segment 212extending from the base portion 220 thereof as with the frame segment210 shown in FIG. 7A. As depicted in FIG. 7C, the frame of the medicaldevice includes multiple frame segments 210 (FIG. 7A) and multiplediscrete occluder segments 240 (FIG. 7B) radially oriented andpositioned in an alternating fashion with, for example, four framesegments 210 and four discrete occluder frame segments 240.

As previously set forth, the frame segments 210 include both an occludersegment 214 and an anchor frame segment 212. As such, in the embodimentshown in FIGS. 7C and 8, there is a total of eight occluder framesegments (four of them being the discrete occluder segments 240).However, the medical device may include fewer or more occluder framesegments. As depicted in the cross-sectional view of the frame of themedical device shown in FIG. 8, such frame segments 210 and discreteoccluder frame segments 240 (not shown in FIG. 8) can be coupledtogether via rings 244 positioned within notches 230 of the base portion220 of the occluder segments 214 to form an occluder hub. Likewise thebase portions 222 of the frame segment 212 may be coupled together viaone or more rings 272 (see FIG. 8A) to form an anchor hub.

With respect to FIG. 8A, an enlarged view of a hub system 250 and adistal portion 252 of the delivery system 254 is shown. The deliverysystem 254 may be similar to the previously described embodiment andinclude a primary catheter 256, a first tubular member 258 and a secondtubular member 260 and a first tethering system 262 and a secondtethering system 264. The first tethering system 262 is configured toconnect to the occluder system at a first eyelet 266 of the base portion220. The second tethering system 264 is configured to connect to theanchor base 228 at a second eyelet 268 defined therein. Further, theanchor base 228 can be interconnected with a hub member 270. The hubmember 270 may be configured to enable advancement of a wire, such as aguide wire, therethrough (not shown).

The hub system 250 may also include a ring member 272 configured to bereceived in a notch 274 defined in the anchor base 228 of each anchorsegment 212. Similar to the previous embodiment, the anchor system—or atleast significant portions thereof—can be retracted within the firsttubular member 258 by pulling the anchor base 228 proximally via thesecond tethering system 264, as indicated by arrow 276. The anchorsystem can also be deployed from the delivery system 254 by moving theanchor base 228 distally from a proximal position to, thereby, roll theanchor segments 212 from the delivery system 254 forming expanded loops,similar to the previous embodiment. It should also be noted that themedical device of this embodiment may be deployed in two ordered orconsecutive stages, similar to that which was described with respect tothe previous embodiment. In other words, the occluder system maydeployed and placed in desired position and orientation within the LAAindependent of the anchor system. The anchor system may be deployedsubsequent to the occluder system in order to secure the occluder systemin its desired position.

FIGS. 9A and 9B show distal and proximal perspective views of anotherembodiment of a medical device 300 according to the present invention.Similar to the previously described embodiments, in this embodiment, themedical device 300 includes an occluder system 302 with a tissue growthmember 306 and an anchor system 304. The occluder system 302 and theanchor system 304 are separately deployable from an associated medicaldevice delivery system, such as that described in FIG. 1 and FIGS. 4Athrough 4D. However, in this embodiment, the occluder system 302 and theanchor system 304 may include various additional features, as describedin detail hereafter. Further, in this embodiment, the occluder system302 is shown as including six occluder frame segments 310 (as opposedto, for example, four or eight that have been described with respect toother embodiments or, in another embodiment, even up to twelve, or, inthe case of employing a wire weave, the number of frame segments couldbe much greater) and the anchor system 304 is shown as including threeanchor frame segments 350 (each anchor frame segment having two roll-outor loop portions). Again, the number of anchor frame segments andoccluder frame segments is merely another example and other numbers offrame segments are contemplated as being used with the various medicaldevices described herein. The anchor frame segments 350 and the occluderframe segments 310 may be positioned and oriented to alternate relativeto each other. Furthermore, in this embodiment, the occluder framesegments 310 do not include the before described front and rearcollapser and expander portions, but rather, each occluder frame segmentmay include a single frame member to which the tissue growth member 306attaches and which facilitates both collapsing and expanding of thetissue growth member 306.

With respect to FIG. 10A, for purposes of clarity, a side view of asingle occluder frame segment 310 is shown. As noted above, the occludersystem 302 (FIG. 9B) may include a plurality of occluder frame segments310, such as six occluder frame segments that form, at least in part,the occluder system. The occluder frame segment 310 of this embodimentmay include a collapser portion 312, an expander portion 314, and anintermediate extension 316. Further, the occluder frame segment 310 mayinclude an outer surface 318 and an inner surface 320. The collapserportion 312 extends radially outward, relative to axis 325, from aproximal end portion 322 of the occluder frame segment 310 to theexpander portion 314. The expander portion 314 likewise extends radiallyoutward relative to the axis 325 from an end of the collapser portion312 to a distal end 324 of the occluder frame segment 310. Theintermediate extension 316 may extend radially inward from a locationthat is generally at, or adjacent to, a proximal end of the expanderportion 314 and may extend in a spaced relationship with an adjacentportion of the collapser portion 312 such that the inner surface 320 ofthe adjacent portion of the collapser portion 312 generally faces theintermediate extension 316. Further, the occluder frame segment 310 alsomay include an occluder base portion 326. The occluder base portion 326may include an occluder leg extension 328 and a protrusion 330 defininga notch 332 configured to interlock with a hub system as will bedescribed in further detail hereafter.

With respect to FIG. 10B, a side view of the single occluder framesegment 310 with the tissue growth member 306 attached thereto is shown.The tissue growth member 306 may include an inner surface 334 and anouter surface 336, the inner surface 334 and outer surface 336, at leastpartially, in contact with the collapser portion 312 and the expanderportion 314 of the occluder frame segment 310. The tissue growth member306 may extend from the base portion 326 of the occluder frame segment310 such that an outer surface 336 of the tissue growth member 306 is incontact with the inner surface 320 of the collapser portion 312 of theoccluder frame segment 310. Further, the occluder frame segment 310 mayextend through the tissue growth member 306 so that the outer surface318 of the expander portion 314 may contact the inner surface 334 of thetissue growth member 306.

With this arrangement, the intermediate extension 316 extends radiallyinward such that the tissue growth member 306 is positioned between aportion of the collapser portion 312 and the intermediate extension 316.Thus, the intermediate extension 316 may assist in holding or attachingthe tissue growth member 306 to the occluder frame segment 310. As theoccluder system 302 is drawn in a catheter, the outer surface 318 of thecollapser portion 312 may contact an inner surface of a catheter lumenand assist in collapsing the tissue growth member 306. Likewise, as theoccluder system 302 is deployed from a catheter, the outer surface 318of the expander portion 314 is configured to assist in expanding thetissue growth member 306 to a position similar to that depicted (it isnoted that only the upper half of the tissue growth member 316 is shownin cross-sectional view in FIG. 10B).

The tissue growth member 306 may also include a plurality of layers ofmaterial. In various embodiments, such layers may include similar ordissimilar materials bonded together by adhesive or by heat processes orother appropriate processes known in the art. Such additional layers mayinclude, for example, an expanded polytetrafluoroethylene (ePTFE)attached to the outer surface of a primary layer of the tissue growthmember. In one embodiment, the tissue growth member 306 may include aprimary layer 306A formed of a polyurethane foam, as set forth in theprevious embodiments. The tissue growth member may further includeadditional layers 306B-306D of materials such as ePTFE thermally bondedwith each other. In one particular example, the outer-most orproximal-most layers 306C and 306D may be formed of an ePTFE materialhaving an internodal distance (sometimes referred to as pore size) ofapproximately 70 .mu.m to approximately 90 .mu.m. The layer of material(306B) adjacent the primary layer 306A may be formed of an ePTFEmaterial having a reduced internodal distance relative to one or more ofthe outer layers 306C and 306D. For example, the internodal distance ofthis layer 306B may be approximately 10 .mu.m. This layer 306B may bebonded or adhered to the primary layer using an adhesive material. Anyother suitable sized layers of ePTFE may be employed, such as ePTFEhaving an internodal distance up to about 250 .mu.m.

Such a configuration effectively prevents the passage of blood, due tothe small internodal distance and pore size of layer 306B, while thelarger internodal distance of other layers (e.g., 306C and 306D) enabletissue in-growth and endothealization to occur. Additionally, theprimary layer, being formed of a polyurethane foam, enables aggressivegrowth of tissue from the LAA wall into the tissue growth member 306. Itis noted that the use of appropriate adhesive materials between theprimary layer 306A and the next adjacent layer 306B may also serve tofill in the pores of the next adjacent layer 306B and further inhibitpossible flow of blood through the tissue growth member 306.

With reference now to FIGS. 11A, 11B and 11C, components of the anchorsystem 304 are shown including a first anchor segment 350 a (FIG. 11A),a second anchor segment 350 b (FIG. 11B) and a third anchor segment 350c (FIG. 11C), each shown in an expanded configuration. Each anchorsegment 350 a-350 c may include a first anchor portion 352 and a secondanchor portion 354, each of which may be substantially similar. Each ofthe first and second anchor portions 352 and 354 extend between a firstouter end 356 and a second inner end 358, the first outer end 356extending from a location that is adjacent an anchor leg extension 360.The second inner end 358 extends from an anchor hub base 362. The anchorleg extension 360 may extend slightly radially inward (toward alongitudinal axis 325 of the device) and distally to a free end 364. Thefirst outer end 356 of the anchor segment portions 352 and 354 may alsoinclude a proximal protrusion 366. The proximal protrusion 366, on itsown or together with a portion of the leg extension 360, may define anotch 368. The notch 368 and the anchor leg extension 360, and theirrelationship with other components, will be discussed in further detailhereafter.

The anchor hub base 362 may vary in structure between each of the firstanchor segment 350 a, the second anchor segment 350 b, and the thirdanchor segment 350 c to include a first anchor hub base 362 a, a secondanchor hub base 362 b, and a third anchor hub base 362 c, respectively.Such structural variation between each anchor hub base may be employedto facilitate interconnection between the individual anchor hub bases362 a-362 c to form, at least in part, the anchor hub system 370 (bestshown in FIG. 13), described in further detail hereafter.

As set forth, each anchor frame segment 350-350 c may include a firstanchor portion 352 and a second anchor portion 354, which, when in theexpanded configuration, may form a first loop configuration and a secondloop configuration, respectively. As in the previous embodiments, thefirst and second anchor portions each include engaging members 372 orprotruding nubs sized and configured to be positioned at a distal sideand on an outer surface of each of the first and second anchor portions352 and 354 when the anchor frame segments 350 are fully expanded sothat the first and second anchor portions 352 and 354 are positionedagainst tissue in the LAA.

With reference to FIG. 12A, the engaging members 372 may include whatmay be termed a wave-crest configuration such that the engaging members372 are oriented and configured to provide traction or engagement withtissue via a tapered edge 384 and such that the engaging members 372only aggressively engage tissue when the medical device experiences adisplacing force in a proximal direction, or otherwise said, in thedirection toward the opening or ostium of the LAA. Further, suchwave-crest configuration of the engaging members may include a peakportion 374 that transitions to the edge 384. The peak portion 374 orouter surface of the engaging members may be blunt or obtuse. As shownin FIG. 12A, the peak portion may be generally rounded to substantiallyprevent the engaging members 372 from piercing or penetrating the tissueof the LAA. In addition, the engaging members 372 may be oriented suchthat the engaging members 372 may extend at an angle .alpha. of aboutone hundred thirty-five degrees from a distal side of the engagingmember 372 relative to a tangent of a surface of the anchor portion 352to, thereby, further prevent the engaging members 372 from piercingtissue while also preventing proximal movement of the medical device.

With reference to FIG. 12B, in another embodiment, each anchor portion352, 354 of each of the respective anchor frame segments 350-350 c mayinclude a wire 376 or other elongated structure wrapped therearound toform a coil configuration. The wire 376 may extend in the coilconfiguration between a first wire-connect portion 378 and a secondwire-connect portion 380 (see FIG. 11A). The wire 376 may be configuredsuch that an radially outer surface 382 is radially inward of the heightof the peak portion 374 of the engaging members 372 and also radiallyinward (or below) the edge 384 of the engaging members 372. In oneembodiment, the wire 376 may be made of a metal or a metal alloy such asstainless steel or titanium, but is not limited to such, and may beformed of other suitable materials, such as Nitinol, a polymericmaterial, a filamentary member or other metals and alloys. Such wire 376may be employed to enhance engaging with the tissue in the LAA as wellas provide a safety feature in the event that the anchor portions 352 or354 of the anchor frame segments 350 a-350 c ever become fatigued andfracture.

Referring back to FIGS. 11A, 11B and 11C, discussion relating to theanchor hub base will now be provided. As set forth, the anchor hub base362 a-362 c for each anchor frame segment 350 a-350 c may includevarying structure such as differently sized and configured notches andslots that may facilitate interconnection of the hub bases 362 a-362 cto form the anchor hub system 370 (FIG. 13). For example, referringspecifically to FIG. 11A, the first anchor hub base 362 a may define,among other things, a first rear notch 390, first retaining notches 392,a first hole 394 and first slots 396. The first rear notch 390 may bedefined between the two second inner ends 358 extending from the firstand second anchor portions 352 and 354. The first retaining notches 392may be defined within an intermediate portion of the first anchor hubbase 362 a at opposite sides thereof. The first hole 394 may be definedproximal of the first retaining notches 392 and the first slots 396 maybe defined at a proximal end portion 398 of the first anchor hub base362 a and, as shown in FIG. 11A, may be formed at angles relative to thelongitudinal axis 325 that extends through the first rear notch 390 andthe first hole 394.

With respect to FIG. 11B, similar to the first anchor hub base 362 a,the second anchor hub base 362 b may define a second rear notch 402 andsecond retaining notches 404. (It is noted that the use of the terms“first,” “second” and “third” in the present discussion are forconvenience in associating the notches, holes or other features with agiven hub base 362 a-362 c and not to denote a particular number ofnotches associated with a particular hub base 362 a-362 c). In addition,the second anchor hub base 362 b may define a deep second proximal notch406. As such, the second rear notch 402 may similarly be defined betweenthe two second inner ends 358 extending from the first and second anchorportions 352 and 354 of the second anchor segment 350 b. The secondretaining notches 404 may be defined within an intermediate portion ofthe second anchor hub base 362 b disposed at opposite sides thereof. Thesecond proximal notch 406 may be defined and extend from a proximal endof the second anchor hub base 362 b between oppositely extending secondprotrusions 408 that at least partially define the second retainingnotch 404. Further, the second proximal notch 406 may be sized andconfigured to be positioned over the first rear notch 390 of the firstanchor hub base 362 a such that the second retaining notches 404substantially correspond and align with the first retaining notches 392and so that the second rear notch 402 associates and corresponds withthe first rear notch 390 (see FIG. 11A).

Referring now to FIG. 11C, the third anchor hub base 362 c may include abase 410 with two base extensions 412. The base 410 may extendtransverse relative to the two second inner ends 358 of the first andsecond anchor portions 352 and 354 of the third anchor segment 350 c.The two base extensions 412 may extend proximally from the base 410 toprovide two opposing pawls 414 facing each other such that, when in arelaxed condition, the pawls may be in contact with one another. The twobase extensions 412 and pawls 414 may be displaced radially outwardly,as shown by arrows 416, to collectively define a third proximal notch418. The third proximal notch 418 may be sized and configured to receivethe first rear notch 390 of the first hub base 362 a and the second rearnotch 402 of the second hub base 362 b so that the two base extensions412 extend over the first anchor hub base 362 a and the pawls 414 latchinto the first hole 394 of the first anchor hub base 362 a (see FIGS.11A and 13). The third anchor hub base 362 c also may define thirdretaining notches 420 defined by a back-side of the pawls 414 (i.e., theopposing, radially outer surface of the extensions) and a proximal sideof the base 410 of the third anchor hub base 362 c.

With reference now to FIG. 13, the anchor hub system 370 with each ofthe first anchor hub base 362 a, the second anchor hub base 362 b andthe third anchor hub base 362 c interconnected together is shown. Asdepicted, the second anchor hub base 362 b and the third anchor hub base362 c are sized and configured to interconnect to the first anchor hubbase 362 a to form the anchor hub system 370. The second anchor hub base362 b and the third anchor hub base 362 c may each be positioned andoriented desired angles relative to the first anchor hub base 362 a suchthat the orientation of each hub base may substantially corresponds withthe orientation of each of the anchor portions (not shown). Further, thepawls 414 of the third anchor hub base 362 c are positioned to extendinto the first hole 394 defined in the first anchor hub base 362 a withthe protrusions 408 of the second anchor hub base 362 b adjacent to thepawls 414 and the first hole 394 of the first anchor hub base 362 a. Inthis manner, the first, second and third retaining notches 392, 404, 420may be substantially aligned such that a band, wire or other retainingdevice (not shown) may be wrapped therearound to ensure each of thefirst, second and third anchor hub bases 362 a-362 c remaininterconnected to maintain the assembly of the anchor hub system 370. Asdepicted, the first anchor hub base 362 a includes the first slots 396defined in a proximal portion thereof. Such first slots 396 may be sizedand configured to interconnect to a release line or tether (not shown)positioned within a coil or pusher member (not shown) similar to thatdescribed previously with respect to FIGS. 3B and 8A. As such, whenappropriate, the anchoring hub system 370 can be released, along withother lines attached to other portions of the medical device (discussedin further detail below), to facilitate release of the medical device inthe LAA.

With reference now to FIGS. 14A and 14B, cross-sections of a hub system308, including anchor leg extensions 360 and occluder leg extensions328, respectively, are shown. For clarity purposes, the anchor hubsystem 370 is simplified and only partially shown. Further, attachmentof the hub system 308 to a catheter system is not shown, but may besimilar to that previously described with respect to FIGS. 3B and 8A.

With respect to FIGS. 11A and 14A, the hub system 308 or primary hubsystem may include, among other things, a hub member 422, a distal endcap 424 and one or more rings 426. The hub member 422 may include aproximal flared portion 428 and a distal end portion 430 to define abore 432 having axis 325 extending therethrough. The distal end cap 424may include a proximal end 434 and a funnel portion 436. The proximalend 434 may slide over a distal end portion 430 of the hub member 422 tointerconnect with the hub member 422 so that each end of the bore 432 ofthe hub system 308 exhibits a flared surface. In another embodiment, thedistal end of hub member 422 may be flared after the installation ofrings 426 to exhibit a flared surface, similar to that provided by thedistal end cap 424. Such process would eliminate the distal end cap 424and a weld.

The funnel portion 436 of the distal end cap 424 may act as a guide tofacilitate the anchor portions (not shown) of the anchor segments toeasily invert or pull into a catheter by pulling on the anchor hubsystem 370. Likewise, the proximal flared portion 428 of the hub member422 facilitates the anchor portions (not shown) of the anchor segmentsto evert or push out of the hub system 308. It is also contemplated thatthe funnel portion 436 of the distal end cap 424 and/or the proximalflared portion 428 of the hub member 422 may include grooves or the likethat may be defined therein to associate and correspond with the anchorportions of the anchor segments to further act as a guide to assist inmaintaining precise alignment of, and substantially preventing overlapbetween, the anchor portions as they are being respectively pulled orpushed through the hub system 308. As with previously describedembodiments, one or more openings 429 may be located at a proximal endof the anchor frame segment 350 for reversibly attaching a release line(not shown) or tether to facilitate release of the medical device.

The flared portion 428 of the hub member 422 may be sized and configuredto be disposed within the notch 368 defined adjacent the first outerends 356 of the anchor frame segments 350 so that the anchor legextensions 360 of the anchor segments 350 extend distally along an outersurface of the hub member 422. The one or more rings 426 may then bepositioned over the anchor leg extensions 360. As depicted in FIG. 15,the one or more rings 426 may have multiple notches 440 defined an innersurface 442 of the ring, each notch 440 being sized and configured toreceive a corresponding anchor leg extension 360 (FIG. 14A) or anoccluder leg extension 328 (FIG. 14B) in an alternating arrangement.With this arrangement, the one or more rings 426 with the notches 440,may be employed to hold the anchor segments 350 and the occluder framesegments 310 to the hub system 308 in a desired pattern or arrangement.Further, the outer surface of the leg extensions 360 and the legextensions 328 (FIG. 14B) may include ramps (not shown) that facilitatethe rings 426 to slide over the leg extensions 360 and 328 and snap/lockthe rings 426 into position.

With reference now to FIGS. 10A and 14B, the hub system 308 is shown toillustrate the occluder frame segment 310 attached to the hub system308. Similar to the leg extensions 360 of the anchor frame segment 350(FIG. 14A), the occluder frame segments 310 also each may include anoccluder base portion 326 defining a notch 332 to receive the proximalflared portion 428 of the hub member 422 and occluder leg extensions 328to be captured within a corresponding notch 440 (FIG. 15) of the one ormore rings 426. It is noted that a portion of only one occluder framesegment 310 and the upper half of the hub system 308 is shown in FIG.14B for purposes of convenience and clarity.

FIG. 16 is a perspective view of the medical device 300 (with out thetissue growth member), illustrating the hub system 308 interconnectedwith the occluder frame segments 310 and the anchor frame segments 350,with the one or rings 426 positioned to capture each of the occluder andanchor frame segments 310 and 350. Further, it should be noted that theoccluder frame segments 310 and anchor frame segments 350 are positionedaround the hub system 308 in an alternating arrangement (i.e., eachoccluder frame segment 310 is disposed between two anchor frame segments350 and vice versa).

Also, it is noted that the occluder frame segments 310 and the anchorframe segments 352 are separate and discrete components of the medicaldevice 300. Further, such occluder frame segments 310 and anchor framesegments 352, as in the previous embodiments, deploy separately, whereinthe occluder frame segments 310 may deploy first so that a physician canreadily determine the best position and orientation of the medicaldevice 300 within the LAA and, once appropriately positioned andoriented, the physician can then deploy the anchoring frame segments 352from the catheter (not shown), as set forth with respect to thepreviously described embodiments. Furthermore, as in previousembodiments, each of the occluder frame segments and the anchor framesegments may be laser cut from a Nitinol sheet, cut with structure andfeatures to employ ready assembly of the medical device and withstructural features to facilitate delivery and release of the medicaldevice through a catheter system or medical device system. Of courseother materials and methods of manufacture may also be used.

With respect to FIGS. 17A and 17B, proximal and distal views of anotherembodiment of a medical device 500 are shown. In this embodiment, theframe structure of the occluder system 502 and the anchor system 504 maybe substantially similar to the previous embodiments set forth, but thetissue growth member 506 may include additional features. For example,the tissue growth member 506 may extend further distally such that thetissue growth member 506 extends a distal distance or extent similar tothe distal distance or extent of the expanded configuration of theanchor system 504. Further, the tissue growth member 506 may includegaps 512 or open sections defined within a distal portion of the tissuegrowth member 506. Such gaps 512 may be areas where portions of thetissue growth member 506 have been removed. The gaps 512 defined in thetissue growth member 506 may be positioned to correspond or align withthe anchor portions 508 or anchor loops of the anchor system 504. Inthis manner, as the anchor system 504 is expanded to an in-use state orexpanded position, the anchor portions 508, including any engagementmembers 510 or nubs, will bias against tissue in the LAA without thematerial of the tissue growth member 506 obstructing the anchor portions508. Additionally, the increased length of the tissue growth member 506may abut the tissue in the LAA (not shown) and provide increased surfacearea contact therewith.

Furthermore, one or more reinforcement lines 514 may extend across thegaps 512 defined in the tissue growth member 506. The reinforcementlines 514 may extend generally laterally or transverse relative to theexpanded anchor portion 508. In one embodiment, the reinforcement lines514 may be a polymer thread or line attached to the tissue growth member506 employing a heat process. With this arrangement, the expanded anchorportion 508 may abut or bias an inner surface of the reinforcement lines514 with the engaging members 510 extending beyond the reinforcementlines 514 to engage the tissue in the LAA. In the currently describedembodiment, the lines 514 extending across the gaps 512 are spaced apartto help ensure that the engaging members 510 extend beyond the lines 514while also providing a radial expansion limit to the anchor portions 508(i.e., a limit regarding how far the anchor portions may radially extendwhen in the deployed state). Such reinforcement lines 514 may provide asafety mechanism in preventing, for example, the expanded anchorportions 508 from over expansion over time as tissue remodeling occursin the tissues surrounding the implanted medical device 500.

FIGS. 18A and 18B are distal and proximal views (photographed) of themedical device 500 with the gaps defined in the distally lengthenedtissue growth member 506 with the reinforcement lines 514 extendingacross such gaps 512, according to another embodiment of the invention.In this embodiment, the tissue growth member 506 may include multiplematerial layers. In one embodiment, the material layers of the tissuegrowth member 506 may include one or more first layers 516 and one ormore second layers 518. The one or more first layers 516 may includefoam, such as polyurethane foam, and the one or more second layers 518may include ePTFE, similar to that described in earlier embodiments.

The ePTFE may include multiple layers, such as two to four layers, ormore. Such ePTFE layers may also include different thicknesses and/orinternodal distances, as previously described. The multiple layers ofePTFE may be sized to substantially prevent blood and thrombi frompassing therethough. The ePTFE layers may be attached to each otheremploying a thermal or sintering process or any other known process inthe art, such as with an adhesive. The one or more layers of ePTFE maybe adhesively attached to the foam layer. In one embodiment, theadhesive layer provided to attach the ePTFE layer to a foam layer alsofills the pores on one side of the ePTFE to further provide a tissuegrowth member that substantially prevents blood and thrombi from passingtherethrough. Further, the surface of the ePTFE on the proximal side ofthe tissue growth member 506 provides a porous surface that readilyfacilitates blood cell lodging and attachment to promote tissue growthand endothealization as this is the surface that is exposed to the leftatrium (“LA”) of the heart (not shown).

In another embodiment, as shown in FIG. 18A, the medical device 500 mayinclude a hub tissue growth member 520. In this embodiment, the hubtissue growth member 520 may be sized and configured to cover theproximal side of the hub (see FIGS. 14A and 14B) of the medical device500. As depicted, with both the tissue growth member 506 and the hubtissue growth member 520, there is substantially no exposure of theframe structure of the medical device 500 at the proximal face of themedical device 500. This feature is advantageous since when the medicaldevice 500 is positioned in the LAA, the proximal face is the surfacethat is exposed to the LA, thereby substantially eliminating thepotential of emboli or thrombus escaping from the LAA to the LA and/ormigrating from exposed frame structure surfaces. In one embodiment, thehub tissue growth member 520 may be formed from multiple layers of ePTFEand/or foam, similar to the tissue growth member 506, previously setforth.

FIG. 19 is a partial cross-sectional view of the anchor hub 522 (insimplified form), depicting the hub tissue growth member 520 attached tothe anchor hub 522. One embodiment of an anchor hub is previouslydescribed in detail and shown with respect to FIG. 13. The anchor hub522 may include notches 524 defined in an outer surface of the hub(including one or more components of the hub). A hole or an eyelet 526may also be formed in a proximal end of the hub 522. The hub tissuegrowth member 520 may include a sock-like member with a proximal face528 and a distal end portion 532. The proximal face 528 of the hubtissue growth member 520 may include a pin hole 530 configured to begenerally aligned with the eyelet 526 of the anchor hub 522. The pinhole 530 is sized and configured to allow a tether (not shown in FIG.19) to extend therethrough for removable attachment to the eyelet 526 ofthe anchor hub 522. The hub tissue growth member 520 may be sized andconfigured to fit over the anchor hub 522 to extend at least to thenotches 524 of the anchor hub 522. The hub tissue growth member 520 maybe attached to the anchor hub 522, for example, with one or more rings534 or ring-like members (including helical type rings) that may bereadily expanded over the anchor hub 522 and tightened over the hubtissue growth member 520 within the notches 524 formed in the anchor hub522. In other embodiments, a thread or filamentary member may be wrappedaround the hub tissue growth member 520 and cinched within the notchesto retain the hub tissue growth member 520 over the anchor hub 522.Other means may also be used to keep the hub tissue growth member 520 ina desired position. With this arrangement, the anchor hub 522 and, moreimportantly, the proximal face 528 of the anchor hub 522 may be coveredwith the hub tissue growth member 520 to optimize the surface exposed tothe LA for endothealization and to prevent emboli or thrombus frommigrating between the LAA and the LA.

In another embodiment, the medical device may include a dissolvingmember 550 configured to provide a limited period in which the loopportions 554 of the anchor segments 552 in the anchor system are biasedor provide outward expansion against tissue within an LAA (not shown).For example, FIG. 20 depicts the dissolving member 550 interconnected tothe anchor hub base 556. For simplification purposes, only one anchorsegment 552 is shown with the dissolving member 550. Such a dissolvingmember 550 may be made of a bio-absorbable material, but may also bemade from a bio-resorbable material or a bio-degradable material orcombinations thereof. As depicted, the dissolving member 550 maypositioned circumferentially about and distally adjacent the anchor hubbase 556 such that the loop portions 554 of the anchor segments 554 arebiased by, or may be supported by or against, the dissolving member 550adjacent the proximal inner end 572 of the loop portions 554.

With this embodiment, the anchoring system can perform and functionsimilar to that described in the previous embodiments when implanted inthe LAA and for a sufficient time while the occluder system (not shown)endothelialized with the tissue in the LAA. After a predetermined timeperiod, the dissolving member 550 degrades or dissolves into the bodysuch that the dissolving member 550 is no longer a component of themedical device. As such, it is no longer present to provide support tothe loop portions 554 of the anchor segments previously provided. Thus,the loop portions 554 of the anchor segments 552 will not provide thesame biasing force against the tissue of the LAA and, instead, will foldor bend (or otherwise be displaced) inward due to structural features inthe anchor hub base 556, described below.

FIG. 20A is an enlarged view of the dissolving member 550 connected tothe anchor hub base 556, as depicted in FIG. 20. The dissolving member550 may be, for example, a cylindrically shaped member, or any othersuitable shape, sized and configured to slide over or otherwise surrounda distal hub extension 560. The distal hub extension 560 may extenddistally and centrally from one of the anchor hub bases 556 of theanchor segments 552. Further, the distal hub extension 560 may include arecessed central region 562 and an enlarged distal portion 564. Therecessed central region 562 may be sized and configured to receive thedissolving member 550 and the enlarged distal portion 564 may be sizedand configured to prevent the dissolving member 550 from disengaging orself-migrating from the distal hub extension 560.

As depicted, the loop portions 554 are disposed against or supported bythe dissolving member 550 on an outer surface 566 of the dissolvingmember 550. The proximal inner end 572 of the loop portions 554 areinterconnected to the anchor hub base 556 with a relatively thinextension 570 disposed therebetween. Such thin extension 570 may besized and configured to limit the outward force of the loop portions 554against the tissue of the LAA by facilitating collapse of the loopportions 554 once the dissolving member 550 has dissolved into the body.In other words, once the dissolving member 550 is dissolved, the thinextension 570, being configured to be relatively non-supportive andflexible, will not provide adequate support for the loop portions 554 toremain biased against the tissue, thereby, allowing collapse (orradially inward displacement) of the loop portions 554. In this manner,the combination of the dissolving member 550 and the thin extension 570employ means by which the medical device may be anchored in the LAA and,after a predetermined period of time in which the dissolving member 550dissolves, the loop portions 554 of the anchoring system may collapse orbecome limp with respect to the tissue in the LAA. As noted above, thedissolving member may be designed to dissolve within a desired timeperiod. For example, the dissolving member 550 may be configured suchthat it dissolves within approximately the same time period as it isanticipated that endothealization will occur, or within a time periodthat correlates with a desired percentage or amount of endothealizationto occur.

Now referring to FIG. 21, a medical device delivery system 600 is shown,according to another embodiment of the present invention. The medicaldevice delivery system 600 may include a medical device 602, a sheath604 and catheter system 608 coupled to a handle system 610. For purposesof reference, an axis 601 is defined as extending through the medicaldevice delivery system 600. The medical device 602 may include anymedical device configured to be interventionally implanted within thehuman anatomy including any one of the medical devices, or combinationsthereof, described herein, such as the medical device that will bedescribed in association with this embodiment. The sheath 604 may be anelongated member defining a sheath lumen 606 extending axiallytherethrough between a proximal end and a distal end of the sheath 604.The sheath may be a discreet, independent member (not permanentlycoupled to the delivery system) sized and configured to receive thecatheter system 608 through the lumen 606 of the sheath 604. It is alsocontemplated that the sheath 604 be incorporated with a sheath handlesystem, which is separate from the handle system 610 described inconjunction with the present embodiment, that may be configured toarticulate a distal end portion of the sheath.

With respect to FIGS. 21 and 21C, the catheter system 608 may include acatheter 622, such as an elongated extruded catheter or member, withmultiple lumens extending along an axial length between a distal end anda proximal end of the catheter 622. For example, the multiple lumens mayinclude a central lumen 624 and one or more peripheral lumens 626, suchas the two peripheral lumens shown in FIG. 21C. Further, the cathetersystem 608 may include multiple tethers extending through the multiplelumens defined in the catheter, the tethers extending and interconnectedto and between the medical device 602 and the handle system 610.

For example, the catheter system 608 may include one or more occludertethers 628 and one or more anchor tethers 630. The central lumen 624may be sized and configured to receive the anchor tether 630 and the oneor more peripheral lumens 626 may be sized and configured to receive theoccluder tethers 628. The anchor tether 630 may include an anchor pusher632, such as a coil or other generally tubular member, with the anchorpusher 632 defining an anchor pusher lumen 634 extending longitudinallytherethrough and multiple wires extending through the anchor pusherlumen 634. Similarly, the occluder tether 628 may include an occluderpusher 636, such as a coil or other generally tubular member, definingan occluder pusher lumen 638 extending longitudinally therethrough andmultiple wires extending through the occluder pusher lumen 638. Each ofthe anchor pusher 632 and the occluder pusher 636 may include apolymeric layer formed therearound.

The occluder tethers 628 and the anchor tether 630 may be connected tothe medical device 602 via the multiple wires, the multiple wiresextending through the respective occluder pushers 636 and anchor pusher632 and extending into and interconnected to the handle system 610.Distal ends of each of the occluder pushers 636 and the anchor pusher632 may not be directly connected to the medical device 602. Themultiple wires may include, for example, a first wire 640 and a secondwire 642, the first wire 640 being a pull wire and the second wire 642being a pin wire. The first wire 640 and second wire 642, actingtogether, may facilitate interconnection and release of the medicaldevice 602 as discussed in further detail herein. With this arrangement,the catheter system 608 may be configured to navigate the vasculature ofa patient and push the medical device 602 through the sheath 604 to theLAA and facilitate manipulation and control of the medical device 602 ata distal portion 621 of the catheter system 608 via the handle system610. Manipulation and control of the medical device 602 may includeseparating out and independently controlling various functionsincluding, for example, the deployment functions of an anchor portion603 (FIG. 21A) and an occluder portion 605 of the medical device 602,optimal positioning and repositioning of medical device 602 in the LAA,re-deployment after fully anchoring the device in LAA, and withdrawingof the medical device 602 from the LAA after fully anchoring the medicaldevice within the LAA.

Referring back to FIG. 21, the handle system 610 may include one or morehandle portions, such as an occluder handle portion 612, an anchorhandle portion 614 and a float handle portion 616, each of which may beutilized to employ different functions to control and manipulate themedical device 602 at the distal portion 621 of the catheter system 608.For example, by retracting the sheath 604, the occluder portion 605 maybe deployed while the handle system 610 is in a first handle position.As depicted in FIGS. 21 and 21A, by distally moving the anchor handleportion 614 forward to a second handle position, as depicted by arrow618, the anchor portion 603 of the medical device 602 may be deployed byeverting or moving one or more anchors distally to a rolled-out positionor an anchor deployed position. Also, as depicted in FIGS. 21 and 21B,by proximally moving the float handle portion 616 to a third handleposition, as depicted by arrow 620, the catheter 622 may also retract toexpose and deploy the occluder tethers 628 and the anchor tether 630connected to the medical device 602 to enable determination of whetherthe medical device 602 is properly seated and positioned in the LAA.

With reference to FIGS. 21, 23 and 24, a more detailed description ofthe handle system 610 will now be provided. FIGS. 23 and 24 arecross-sectional views of the handle system 610, taken along sectionlines 23 and 24 shown in FIG. 22, FIG. 22. illustrating an end view ofthe proximal side of the handle system 610. Beginning on a distal sideof the handle system 610, the float handle portion 616 may include anouter housing 644 defining a bore 646 extending axially through theouter housing 644 between a distal end and a proximal end thereof. Theproximal end of the catheter 622 may be coupled to the distal end of theouter housing 644, such as by being inserted and secured within the bore646 of the float handle portion 616. The proximal end of the floathandle portion 616 may be slidably coupled to an inner extension 652 ofthe occluder handle portion 612, the inner extension 652 being sized andconfigured to slide within the bore 646 of the float handle portion 616.The float handle portion 616 may be limited to linear translation overthe inner extension 652 such as by way of interaction between a groove648 defined in the inner surface (within the bore) of the outer housing644 and a guide 654 formed on the inner extension 652. The outer housing644 of the float handle portion 616 may also be coupled to a float rod650 extending proximally from the float handle portion 616 and throughthe occluder handle portion 612 as will be discussed in more detailhereafter. With this arrangement, the float handle portion 616 islinearly slideable over the inner extension 652 of the occluder handleportion 612. Since the proximal end of the catheter 622 is fixed withinthe bore 646 of the float handle portion 616, proximal movement, asindicated by arrow 620, of the float handle portion 616 will retract thecatheter 622 of the catheter system 608 to, thereby, enable the floatfeature for the medical device 602, as previously discussed.

With respect to FIG. 24A, an enlarged view of a portion of the floathandle portion, taken from detail “24A” of FIG. 24, is shown. Tomaintain the integrity of the occluder pusher 636 and associated wires(not shown in FIG. 24A) extending through the catheter system 608 andthe handle system 610 when proximally moving the float handle portion616, tubing 653, such as hypo-tubes, may be co-axially secured with thelumens defined in the inner extension 652 that, in turn, correspondco-axially with, and slidably extend toward, the peripheral lumens 626defined in the catheter 622 (see FIG. 21). The lumens defined in theinner extension 652 may include a catheter portion corresponding to theconfiguration of the catheter 622 or may include an associated housingportion positioned within a bore defined in the inner extension 652. Inthis manner, as the float handle portion 616 is moved proximally, theoccluder pusher (coils) and wires maintain a substantially straightenedposition while the catheter 622 is retracted. During the proximalmovement of the catheter 622, the tubing 653 may be fixed within theinner extension 652 and slides within the peripheral lumens 626 definedin the proximal end of the catheter 622. The tubing 653 arrangement maytherefore substantially prevent buckling of the coils and wires duringproximal movement of the float handle portion 616 toward the innerextension 652.

Referring back to FIGS. 23 and 24, the occluder handle portion 612, ormiddle portion of the handle system 610, may include an outer housing658, the above-identified inner extension 652 and an occluder-releaseslider 660. The outer housing 658 may define a bore 662 extendingaxially between a proximal end and a distal of the outer housing 658.Such outer housing 658 may be sized and configured to house the innerextension 652, the occluder-release slider 660 and a mode switch 664.The mode switch 664 may be secured in the outer housing 658 at theproximal end with mode support structure 666.

The inner extension 652 may extend axially through the bore 662 of theouter housing 658, coupled at one end to the mode support structure 666.The other end of the inner extension 652 extends axially and distallyfrom the outer housing 658 of the occluder handle portion 612 and isslidably coupled with, and extends through a portion of, the floathandle portion 616. The inner extension 652 may also extend through aslider bore 661 defined in the occluder-release slider 660. In theposition depicted, the occluder-release slider 660 is fixed to the innerextension 652 via a notch 668 and a spring-loaded pawl 670 arrangementsuch that the pawl 670 may be moved from the notch 668 defined in theinner extension 652 to enable the occluder-release slider 660 to bemoved proximally as will be discussed in more detail hereafter. Thespring-loaded pawl 670 may be configured, for example, as a partialring-type clip that may be positioned around the occluder-release slider660 with the pawl 670 extending through a hole or slit 672 in theoccluder-release slider 660 and further extending into the notch 668 ofthe inner extension 652.

With reference to FIGS. 24 and 24B, FIG. 24B depicts an enlarged portionof the occluder-release slider 660 coupled to occluder tether wires(shown as dashed lines). In one embodiment, the occluder-release slider660 may define two holes 674 extending transverse relative to the axis601 of the medical device delivery system 600 and which may be axiallyaligned with each other. Further, the occluder-release slider 660 maydefine a primary groove 676 formed in an outer surface of theoccluder-release slider 660 that is sized and configured to secure theoccluder tether wires thereto. Also, the inner extension 652 may definetwo opposing notched openings 678 extending generally between the boreof the inner extension 652 and the outer surface of the inner extension652. The proximal ends of the notched openings 678 may extend to, andcorrespond with, the holes 674 of the occluder-release slider 660. Thedistal ends of the notched openings 678 extend to longitudinal guidegrooves 680 defined in the inner surface of the occluder-release slider660.

In one embodiment, there can be two sets of occluder tether wires. Aspreviously set forth, each set of occluder tether wires may include thefirst wire 640 and the second wire 642, the first wire 640 being thepull wire and the second wire 642 being the pin wire (see also FIG.21C). In regard to one set of the occluder tether wires, the first wire640 may extend from the peripheral lumen 626, through one notchedopening 678 of the inner extension 652, along the guide groove 680defined in the occluder-release slider 660, around the distal end of theoccluder-release slider 660 and toward the primary groove 676 to becircumferentially wrapped around and secured within the groove 676 Thesecond wire 642 or pin wire may also extend through the notched opening678 of the inner extension 652, through the hole 674 and around an outersurface of the occluder-release slider 660, and into the primary groove676 to be wrapped and secured therein. The other set of occluder tetherwires may be similarly secured to the occluder-release slider 660 byextending through the inner extension 652 on the opposite side thereofand wrapped around the primary groove 676 of the occluder-release slider660, as depicted. It is also noted that the anchor tether 630 (shown asdashed line) axially extends through the occluder handle portion 612toward the anchor handle portion 614.

With respect to FIGS. 23 and 23A, the mode switch 664 will now bediscussed. As previously set forth, the occluder handle portion 612 mayinclude the mode switch 664 at a proximal side thereof. The mode switch664 may include a switch that is moveable, for example, between a firstposition and a second position. The mode switch 664 may be secured tothe occluder handle portion 612 via the mode support structure 666. Forexample, as best depicted in FIG. 24, the mode support structure 666 mayinclude a proximal end of the inner extension 652 or an inner discmember 667 secured to an outer disc member 669 with at least a portionof the mode switch 664 sandwiched therebetween. The inner disc member667 may be sized to fit snugly within the outer housing 658 and theouter disc member 669 sized to cap-off the proximal end of the outerhousing 658 of the occluder handle portion 612. The proximal end of theinner extension 652 may be fixed to the inner disc member 667. Such aconfiguration may be employed to sufficiently hold the mode switch 664in position and facilitate translation of the mode switch 664 tomultiple positions.

Referring again to FIGS. 23 and 23A, the mode switch 664 may include oneor more key holes defined therein, such as a first key hole 682, asecond key hole 684 and a third key hole 686. Each of the one or morekey holes 682, 684 and 686 may be sized and configured to correspondwith different portions of the handle system 610, such as a release rod688, an anchor rod 690 and the float rod 650, respectively. Each ofthese rods may act as a key relative to the position of the mode switch664 and their corresponding key holes. The release rod 688 and anchorrod 690 are fixed to the anchor handle portion 614 and extend distallytherefrom, extending through the one or more key holes and into theoccluder handle portion 612. The release rod 688 and anchor rod 690 maybe selectively slideable through the occluder handle portion 612relative to the mode switch 664. For example, the first key hole 682 maybe sized and configured to receive a flattened section of the releaserod 688 such that the release rod 688 may slide to different positions(or rotate) depending on the position of the mode switch 664. Likewise,the second key hole 684 may be sized and configured to receive theanchor rod 690, slideable therethrough depending on the position of themode switch 664. Similarly, the third key hole 686 may be sized andconfigured to receive the float rod 650 such that the float rod 650 maybe slidably displaced therethrough depending on the relative position ofthe mode switch 664. Additional detail regarding the mode switch 664,its positioning and the control and functionality it provides to themedical device delivery system 600 (FIG. 21), will be discussed infurther detail below.

Referring back to FIGS. 21, 23 and 24, the anchor handle portion 614 mayinclude an outer housing 692, an anchor handle fixed member 694 and ananchor-release slider 696, each defining axially extending stepped borestherein. Further, the anchor handle portion 614 may include arelease-enable switch 698 disposed at a proximal end thereof (also seeFIG. 22). Such structural components of the anchor handle portion 614may be positioned relative to each other in a variety of ways. Forexample, the anchor handle fixed member 694 may be fixed to the anchorrod 690 such that the anchor rod 690 sealingly extends through thedistal end of the anchor handle fixed member 694 into a larger portionof the bore defined in the anchor handle fixed member 694. Theanchor-release slider 696 may be positioned over the proximal end of theanchor rod 690 and within the proximal side of the bore defined in theanchor handle fixed member 694.

The proximal side of the outer housing 692 may be positioned over boththe anchor handle fixed member 694 and the anchor-release slider 696with a fluid port 702 extending axially through the proximal side of theouter housing 692 and through the proximal portion of the anchor-releaseslider 696 to interconnect with the anchor rod 690 to facilitate fluidcommunication through the handle system 610 and to the catheter system608. One or more sealing rings 704 may be employed for sealinginterconnection between the fluid port 702 and the anchor rod 690.Further, the anchor handle fixed member 694 includes a longitudinalextending bore, off-set from a longitudinal axis of the anchor handlefixed member 694, that may be sized and configured to receive therelease rod 688. The release rod 688 may be linearly fixed andselectively rotatable relative to the outer housing 692, extendingthrough the anchor handle fixed member 694 and extending through theoccluder handle portion 612. With this arrangement, the outer housing692 and the anchor-release slider 696 may be fixed to each other.Further, the anchor fixed member 694 and the outer housing 692 may befixed in the position depicted. However, once the anchor handle portion614 is moved distally to the occluder handle portion 612 and the modeswitch 664 is moved to an “anchors locked—float enabled” position, therelease-enable switch 698 may be actuated or rotated, which allows eachof the anchor-release slider 696, the outer housing 692 and the releaserod 688 to be slidably movable relative to the anchor fixed member 694as will be described in greater detail when discussing the releasing ofthe medical device hereafter.

With respect to FIG. 24C, an enlarged view of the anchor handle portion614 taken from detail “24C” of FIG. 24 is shown, depicting the anchorhandle portion 614 interconnected with the anchor tether wires (shown indashed lines). The anchor tether wires may extend axially through theanchor rod 690 and through a portion of the anchor handle portion 614.Similar to the occluder tether wires, the anchor tether wires mayinclude the first wire 640 and the second wire 642, the first wire 640being a pull wire and the second wire 642 being a pin wire. The firstwire 640 may be configured to extend out of the anchor rod 690 andbetween an outer surface of the anchor rod 690 and an inner surface ofthe anchor-release slider 696. The first wire 640 may further extendaround the distal end of the anchor-release slider 696 and along anouter surface of the anchor-release slider 696. As depicted, there maybe a descending groove along a longitudinal length of the outer surfaceof the anchor-release slider 696 for the first wire 640 to extend along.The descending groove may extend to a radial groove 706 formed in aproximal portion of the anchor-release slider 696. As such, the firstwire 640 can extend to the radial groove 706 and be circumferentiallywrapped around and secured within the groove 706. With respect to thesecond wire 642, such second wire 642 may extend axially from the anchorrod 690, through a bore 708 of the anchor-release slider 696, over aproximal end of the anchor-release slider 696, through a groove formedin a proximal portion of the anchor-release slider 696, and into theradial groove 706 formed in the proximal portion to be wrapped andsecured within the radial groove 706 of the anchor-release slider 696.With this arrangement, upon releasing the medical device within an LAA(not shown in FIG. 24C), the anchor-release slider 696 may moveproximally, thereby pulling the second wire 642 before pulling the firstwire 640 due to the slack of the first wire being wrapped around thedistal end of the anchor-release slider 696. Additional detail relatingto release of the tether wires will be provided hereinbelow.

Now referring to FIGS. 25 and 25A the handle system 610 is showndepicting the anchor handle portion 614 moved distally forward to asecond handle position as associated with an anchor-deployed position ofa medical device 602. Note that FIG. 25 is the same cross-sectional viewas FIG. 23, but in the second handle position. In the anchor-deployedposition, the anchor handle portion 614 may move to abut the occluderhandle portion 612. With such movement, the anchor rod 690 and therelease rod 688 also move distally the same linear distance toward, andwithin, the occluder handle portion 612. Movement of the anchor rod 690in a distal direction also moves the anchor tether 630 (FIG. 21C)forward a substantially similar distance to deploy the anchor portion603 of the medical device 602 (see, e.g., FIG. 21A) due to being axiallycoupled together. Movement of the release rod 688 in the proximaldirection positions an abutment edge 710 (FIG. 34B) of the release rod688 through a release rod hole 712 (FIG. 34A) defined in theoccluder-release slider 660 and adjacent the pawl 670 of theoccluder-release slider 660.

Placing the mode switch 664 in the first position enables movement ofthe anchor handle portion 614, and thus movement of an anchor portion ofa medical device. With the mode switch in the first position or “downposition,” as depicted in FIGS. 25 and 25A, the anchor handle portion614 can move freely between the anchor-deployed position and theanchor-retracted position. Such control over deployment and retractionof the anchors, independent of other components, such as the occluder,is advantageous for a physician to obtain optimal placement andpositioning of a medical device within the LAA.

With respect to FIGS. 26 and 26A, the handle system 610 is showndepicting the float handle portion 616 retracted proximally to a thirdhandle position associated with a tether-deployed position for a medicaldevice 602. In order to enable movement to the third handle position,the mode switch 664 has been moved from the first position (describedabove) to a second position or “upward position,” as depicted in FIGS.26 and 26A. Such upward movement changes the configuration of each ofthe key holes, or at least a portion of the key holes that respectivelycorrespond with the release rod 688, the anchor rod 690 and the floatroad 650. Further, as previously set forth, each of the release rod 688,the anchor rod 690 and the float rod 650 include a key configurationalong a selective portion of their respective lengths that can act as akey. These key portions will facilitate actuation, or prevent actuation,of each of the anchor handle portion 614, float handle portion 616 oractuation of the release-enable switch 698.

For example, with the mode switch 664 in the second position, actuationof the anchor handle portion 614 may be prevented by engagement with ananchor rod notch 714 (FIG. 24) defined in the anchor rod 690. Forexample, when the anchor handle portion 614 has been moved and the modeswitch 664 is placed in the second position, the narrowed portion of thesecond key hole 684 engages the anchor rod notch 714 of the anchor rod690 to, thereby, prevent the anchor handle portion 614 from furthermovement. Similarly, the float rod 650 may also define a float rod notch716 (FIG. 23) corresponding with the third key hole 686 and configuredto prevent movement of the float handle portion 616 until the anchorhandle portion 614 is moved to the second handle position and the modeswitch 664 is moved to its second position. Further, the release rod688, with the mode switch 664 in the second position, is keyed to allowrotational movement, whereas in the first position the release rod 688is keyed to prevent rotational movement. More specifically, the firstkey hole 682 includes a square-like or rectangular portion 718 thatcorresponds with the release rod 688 while the mode switch 664 is in thefirst position (see FIG. 25A) to prevent rotational movement. However,when the mode switch 664 is placed in the second position, the first keyhole 682 includes a round portion 720 that corresponds with the releaserod 688 to enable rotational movement. (also see FIG. 25A).

With the mode switch 664 in the second position, the float handleportion 616 may be retracted proximally and axially a defined distance.For example, the float handle portion 616 may be displaced until it ispositioned against the occluder handle portion 612. With such proximalmovement, the float rod 650 also moves proximally into a portion of theanchor handle portion 614. Further, movement of the float handle portion616 proximally moves the catheter 622 proximally since the proximal endof the catheter 622 is fixed to the float handle portion 616. In thismanner, the tethers, such as the occluder tethers 628 and the anchortethers 630 maintain their axial position and are deployed from thecatheter 622 (see FIG. 21B), thereby, limiting the resistance or biasingforce placed on the implanted medical device by the still-attacheddelivery system. If desired, the tethers may be re-sheathed within thecatheter 622 by simply moving the float handle portion 616 distally toits earlier position. Further, if desired, the anchor portion of themedical device may be retracted by simply moving the mode switch 664back to the first position and then moving the anchor handle portion 614proximally.

With reference to FIGS. 27-29, the handle system 610 is shown in arelease position to release a medical device 602 from the deliverysystem 600. The release-enable switch 698 is moved to a releaseposition, best shown in FIG. 27 (as compared to the non-releasedposition shown in FIG. 22), which may be rotated about a release-enableswitch pivot 722 in a clock-wise manner. In addition, release-enableswitch 698 may define a radial opening 724 extending a distance in whichthe release-enable switch 698 travels to be placed in the releaseposition. The fluid port 702 extends proximally through the radialopening 724 defined in the release-enable switch 698.

FIGS. 28 and 29 are cross-sectional views of the handle system 610 takenalong section lines 28 and 29 of FIG. 27, respectively, depicting someof the components of the handle system 610 in the release position. Itis noted that the outer housing 692 (FIG. 23) of the anchor handleportion 614 not shown for purposes of convenience and clarity. However,it is also noted that such outer housing, as previously set forth, isfixed to the anchor-release slider 696 and, therefore, the outer housingmay move with the anchor-release slider 696 when moved to the releaseposition.

In the release position, the release rod 688 is retracted proximally. Inone embodiment, such retraction of the release rod 688 also moves theanchor-release slider 696 and the occluder-release slider 660proximally, but leaves or maintains the anchor handle fixed member 694against the occluder handle portion 612. Note that the pawl 670 of theoccluder-release slider 660 is moved from the notch 668 of the innerextension member 652, thereby, enabling the occluder-release slider 660to be moved by the release rod 688 to the released position, as will beshown and described in greater detail with respect FIGS. 34-35. In thismanner, the occluder-release slider 660 and the anchor-release slider696 can be moved proximally in a simultaneous arrangement.

As previously set forth, with respect to FIGS. 24B, 24C and 28, thefirst wire 640 and the second wire 642 of each of the occluder tethers628 and the anchor tether 630 are fixed to the respectiveoccluder-release slider 660 and the anchor-release slider 696. Inparticular, the first wires 640 of the occluder tethers 628 and anchortether 630 may be wrapped distally and then proximally around a proximalportion of the respective occluder-release slider 660 and theanchor-release slider 696. Further, the second wires 642 of the occludertethers 628 and the anchor tether 630 may extend proximally to therespective occluder-release slider 660 and anchor-release slider 696. Inthis manner, once the occluder-release slider 660 and the anchor-releaseslider 696 are retracted proximally, the distal end of the second wire642 is displaced proximally before the distal end of the first wire 640is displaced proximally due to a slack distance 726 provided by theproximal wrapping of the first wire 640. In other words, the first wire640 is not moved proximally, along its length, until the slack distance726 is overcome by the moved distance the occluder-release slider 660and the anchor-release slider 696 has moved proximally. In thisembodiment, the distance the sliders move to overcome the slack distance726 is about twice the slack distance 726 for the respectiveoccluder-release slider 660 and the anchor-release slider 696. With thisarrangement, as depicted in FIG. 39, the second wire 642 may be pulledfirst as indicated by arrow 732, moving from a loop 728 formed by thefirst wire 640 that extends through an eyelet 730 of the medical device602 and, once the slack distance 726 (FIGS. 24B and 24C) is overcome,the first wire 640 is pulled from the eyelet 730, thereby releasing theoccluder tethers 628 and the anchor tether 630 from the medical device602.

As depicted in FIGS. 26A and 28A, the mode switch 664 is in the secondposition or upward position. The second position of the mode switch 664enables the release rod 688 to rotate within the round portion 720 ofthe first key hole 682, which movement of the mode switch 664 to thesecond position may be employed at anytime subsequent to deploying theanchor portion of the medical device 602. In other words, it is notnecessary to employ the float feature by retracting the float handleportion 616 in order to move the mode switch 664 to the second positionto enable rotation or actuation of the release-enable switch 698. Inthis manner, movement of the float handle portion 616 and/or movement ofthe release-enable switch 698 may be employed with the mode switch 664in the second position or the upward position as depicted in FIGS. 26Aand 28A.

Now referring to FIGS. 30-33, additional details relating to the releasefeature of the anchor handle portion 614 will now be discussed. It isnoted that FIGS. 31-33 do not show the outer housing 692 of the anchorhandle portion 614 for purposes of clarity in showing the variouscomponents and features of the anchor handle portion. FIG. 30 shows anenlarged cross-sectional proximal portion of the anchor handle portion614, taken along section line “30” of FIG. 22, and depicts therelease-enable switch 698 in a first position or non-released position.The outer housing 692 of the anchor handle portion 614 may define acavity 734 therein. The cavity 734 may have a spring-loaded pin 736positioned therein. While the release-enable switch 698 is in the firstposition, the spring-loaded pin 736 may be in a restrained position(i.e., as shown in FIG. 30). Further, while the release-enable switch698 is in the first position, a release rod projection 738 of therelease rod 688 is positioned in an elbow groove 740 defined in theanchor handle fixed member 694, as depicted in FIG. 31. In this manner,the anchor fixed member 694 may be operatively coupled or fixed to theanchor-release slider 696 and directly coupled to the release rod 688.

As depicted in FIGS. 32 and 33, once the release-enable switch 698 isrotated to the second position (the second position best shown in FIG.27), the spring loaded pin 736 moves or springs to an exposed recess 742defined in the release-enable switch 698, which may irreversibly fix therelease-enable switch 698 in the second position. Also, when therelease-enable switch 698 is rotated to the second position, the releaserod 688 also rotates, thereby, rotating the release rod projection 738extending from the release rod 688 out of a coupled position relative tothe anchor fixed member 694. As depicted in FIG. 33, with the releaserod projection 738 being positioned to enable linear movement, therelease rod 688 and a portion of the anchor handle portion 614, namely,the anchor-release slider 696 and outer housing (not shown), may belinearly retracted in a proximal direction.

Now referring to FIGS. 34, 34A, 34B and 35, additional description willnow be provided for the release rod 688 employing movement of theoccluder-release slider 660. Again, the outer housing of the occluderhandle portion is not shown for purposes of clarity. With reference toFIGS. 34, 34A and 34B, the release rod 688 is configured to act as a keydefining multiple structural features that assist in controlling thefunctionality of the handle system 610. For example, the release rod 688may have an elongated narrow portion 744 defined on a distal portion ofthe release rod 688 that is sized and configured to slide or linearlymove under the pawl 670 of the occluder-release slider 660. Theelongated narrow portion 744 may be formed by removing, for example,about one-half to two thirds of an upper elongated portion of therelease rod 688 so that when the release rod 688 is oriented in a firstposition, as depicted, the elongated narrow portion 744 is oriented soas to easily slide under the pawl 670 when moved distally. The proximalend of the elongated narrow portion 744 may include a release rod notch746 defined therein, as best depicted in FIG. 34B. The release rod notch746 may be sized and configured to catch or couple to theoccluder-release slider 660 so that the release rod 688 can retract theoccluder-release slider 660.

As depicted in FIGS. 35 and 35A, the mode switch 664 is moved to thesecond position or upward position. As previously set forth, the secondposition of the mode switch 664 allows rotational movement of therelease rod 688. As shown in FIGS. 35 and 35A, the release rod 688 is ina rotated position. However, before such rotation of the release rod 688and movement of the mode switch 664 to the second position, the releaserod 688 is moved forward to deploy the anchor portion of the medicaldevice 602. In the rotated position, the release rod 688, via therelease rod notch 746 (FIG. 34B) in the release rod 688, can catch theoccluder-release slider 660. Further, in the rotated position, the pawl670 is moved upward via such rotation, the pawl 670 moving out ofengagement with the notch 668 defined in the inner extension 652 of theoccluder handle portion 612, thereby, decoupling the occluder-releaseslider 660 from the inner extension 652. The proximal movement of therelease rod 688 can then proximally retract the occluder-release slider660 such that it is adjacent the mode switch 664. As previously setforth, such proximal movement of the release rod 688 simultaneouslyretracts the occluder-release slider 660 and the anchor-release slider696 (not shown in FIGS. 35 and 35A) for substantially simultaneouslydetaching the occluder tethers and the anchor tether from the medicaldevice.

Referring now to FIGS. 36-40, a cross-sectional view of a medical device602 coupled with a medical delivery device (e.g., delivery device 600 inFIG. 21) is shown in accordance with another embodiment of the presentinvention. The medical device 602 includes an occluder portion 605 andan anchor portion 603. The medical device 602 depicted herein is similarto the medical device depicted in FIGS. 9A and 9B, with three anchorsegments having six anchor loops 748 (two anchor loops 748 per anchorsegment) and six occluder frame segments 750 each positioned andoriented around a hub 752 in an alternating fashion. For simplisticpurposes, the cross-sectional views in FIGS. 36-40 depict the anchorloops 748 and occluder frame segments 750 as being rotated into the sameplane, though in this embodiment they may be oriented around the hub 752in the alternating arrangement set forth in the above-noted embodiment.

Description of the various positions of the medical device 602, relativeto the medical device delivery system, will now be set forth. Beforeintroducing the medical device 602 to the LAA (not shown in FIGS. 36-40)the sheath 604 may first be introduced to the LAA. As known by one ofordinary skill in the art, the sheath may be introduced into thevasculature extending toward and into the right atrium of the heart. Forexample, access into the right atrium may be gained through the femoralvein. The sheath 604 may then be introduced into the left atrium, via atrans-septal puncture, and then positioned within an LAA, preferably, inthis embodiment, positioning a distal end of the sheath at a rearlocation relatively deep within the LAA, located and positioned throughconventional procedures and imaging techniques.

Once the sheath 604 is positioned in the LAA, the medical device 602 maybe pushed through the sheath 604, beginning at the proximal end of thesheath 604, toward the LAA, as depicted in FIG. 36. The medical device602 may be introduced into the sheath 604 via a loader 754 (see FIG. 21)positioned around the catheter 622. The loader 754 may be moved to adistal end 758 of the catheter 622 against the deployed occluder portion605 and pulled within the loader 754. The end of the loader 754 may thenbe inserted into the proximal end of the sheath 604 so that the catheter622 can be manually advanced through the sheath 604 thereby, advancingthe medical device 602 to a distal portion of the sheath 604 and intothe LAA. As depicted, having been advanced by the catheter 622 towardthe distal end of the sheath 604, the anchor portion 603 of the medicaldevice 602 is retracted within a distal portion 756 of the catheter 622with the occluder portion 605 positioned distally relative to a distalend 758 of the catheter 622. Once the medical device 602 is positionedat a distal portion of the sheath 604 within the LAA, the occluderportion 605 may then be deployed by manually retracting the sheath 604,as depicted by arrow 760, which facilitates deployment of the occluderportion 605 of the medical device 602.

As depicted in FIG. 37, the sheath 604 is in a retracted position withthe occluder portion 603 in a deployed position. Such occluder portion605 may automatically deploy by retracting the sheath 604 due to theself expanding characteristics of the occluder frame segments 750. Theoccluder portion 605, in this embodiment, may not have any anchoringfunction, but rather, as previously described, includes a tissue growthpromoting member 762 with one or more layers that provide a soft andsupple occluder portion 605. Through imaging techniques, a physician canslowly pull the occluder portion 605 of the medical device 602 from arear position within the LAA toward a desired position, stopping andanalyzing multiple different positions and orientations within the LAAuntil determining an optimal or preferred position, for example,adjacent to the ostium and within the LAA. If the physician at any timebelieves that the occluder portion 605 has been pulled beyond theoptimum location in the LAA or from the LAA, the physician can readilyre-capture the occluder portion 605 by simply moving the sheath 604distally. The sheath 604 can then be advanced again deep within the LAAand the occluder portion 605 re-deployed and then retracted to anoptimal position for the occluder portion 605 to be positioned. Once theoptimal position is located in the LAA, the physician may deploy theanchor portion 603 of the medical device 602 by moving the anchor handleportion 614 in a distal direction to the second handle position (seeFIG. 21). Such movement of the anchor handle portion 614 to the secondhandle position moves the anchor pusher 632 distally, as indicated byarrow 764, to, thereby, move the anchor portion 603 of the medicaldevice 602 distally from a retracted position to a deployed or expandedposition (FIG. 38) Likewise, the anchor portion 603 can be moved backfrom the deployed position to the retracted position.

As shown in FIG. 37 and described in detail in previous embodiments, theanchor portion 603 may include multiple anchor loops 748, each includinga first end 749 and a second end 751. The first end 749 of each anchorloop 748 being coupled to the hub 752 and each second end 751 beingcoupled together to form the anchor hub. When the anchor portion 603 isin the retracted position, the first end 749 and second end 751 of eachanchor loop 748 may be proximal to a distal end of the occluder portion605. Further, the second ends 751 of the anchor portion 603 may beproximal to the hub 752. Also, when the anchors are in the retractedposition, the distal end of the anchor portion 603, e.g., the distal endof anchor loops 748, are proximal to the distal end of the occluderportion 605. With this arrangement, the anchor portion 603 mayindependently move between the retracted position and the deployedposition when the occluder portion 605 is deployed, thereby, providingthe physician the ability to selectively anchor the occluder portion 605at a preferred location and orientation within the LAA.

As depicted in FIG. 38, the anchor pusher 632 is moved to the distal end758 of the catheter 622 to, thereby, deploy and move the anchor portion603 of the medical device 602 from the retracted position to thedeployed position. In the deployed position, the first end 749 andsecond end 751 of each of the anchor loops 748 remain proximal to thedistal end of the occluder portion 605 with a portion of the anchorloops 748 extending distal to the distal end of the occluder portion605.

As previously described with respect to the other embodiments, theanchor loops 748 or a portion of the anchor portion 603 may roll-outthrough the hub 752, having been pushed by the anchor pusher 632, in aneverting type arrangement. In this manner, the anchor portion 603 can bemoved between the retracted position and the deployed position, asdepicted in respective FIGS. 37 and 38, with an intermediate portion ofthe anchor portion 603 being moveable or displaceable through a bore ofthe hub 752. In one embodiment, the anchor portion 603 can roll-inwardto the retracted position and roll-outward to the deployed position. Inanother embodiment, the anchor portion 603 can be moved to a retractedposition by at least partially inverting the anchor portion 603 throughthe hub 752. In another embodiment, the anchor portion can be moved to adeployed position by at least partially everting the anchor portion 603through the hub 752.

Referring to FIG. 38, the anchor portion 603 may include multiple anchorloop portions, such as six anchor loops 748 in this embodiment, withengaging members 766 sized and configured to engage tissue in the LAA.In this embodiment, the anchor loops 748 may include an anchor contactportion 768 proximal to the most proximal engaging member 766 of a givenanchor loop 748. The anchor contact portion 768 includes an outersurface of the anchor loop 748 that may abut against an undersideportion 770 of the occluder portion 605. The underside portion 770 ofthe occluder portion 605 may include a ribbon portion 772 of the tissuegrowth member 762, which may be more firm and unyielding (having lesselasticity) than other portions of the tissue growth member 762. Theribbon portion 772 may be sewn to the occluder portion 605 and/oradhesively attached. Further, the ribbon portion 772 may be generallycircular in shape to cover the underside of the distal end of theoccluder portion 605. The ribbon portion 772 may be formed of, forexample, a biocompatible woven fabric, or any other suitable materialthat also will promote tissue in-growth and provide a more firm andunyielding surface area than the other portions of the tissue growthmember 762. Also, it is noted that although FIG. 38 depicts the occluderportion 605 and anchor portion 603 in their fully expanded positions,such that the anchor portion may be pre-loaded (or slightly constrained)to provide force against the ribbon portion 772 of the occluder portion605. Further, such anchor and occluder portions 603 and 605 may besomewhat compressed within the LAA such that the anchor portion 603 andoccluder portion 605 may provide a radially outward force against thetissue of the LAA. As such, as the anchor portion 603 is deployed, theanchor contact portion 768 of the anchor loops 748 may be configured tobias and push outward against the ribbon portion 772 or undersideportion 770 of the occluder portion 605 so that the occluder portion 605is pushed against the tissue with the engaging members 766 engagingtissue distal the occluder portion 605 in the LAA.

In one embodiment, when the anchor portion 603 is in the deployedposition (FIG. 38), the engaging members 766 may be oriented to extendproximally and, when the anchor portion 603 is in the retracted positionthe engaging members 766 may be oriented to extend distally (FIG. 37).The change in orientation of the engaging members 766 may occur, in oneembodiment, due to inverting and everting the anchor portion 603 whenmoving the anchor portion between the retracted position and thedeployed position. For example, when the anchor portion is moved fromthe deployed position to the retracted position, an outer surface of theanchor loops 748 adjacent the engaging members may be rolled-inward orinverted such that the outer surface is moved to become an inner surfaceof the anchor loops 748.

In other embodiments, the position of the engaging members 766 maychange by moving the engaging members between a tissue-engaging positionand a tissue-non engaging position such that the engaging members 766are moved away from the tissue surface to, thereby, allow positioning orrepositioning of the occluder portion 605. Such may be employed with anextension portion, which may be defined as the portion of the anchorloops 748 extending inwardly and proximally from adjacent the engagingmembers 766 and configured to be pulled proximally to move the engagingmembers 766 from the tissue-engaging position to the tissue-nonengagingposition while the occluder portion 605 remains in a deployed position.Other embodiments including an extension portion or extension member asa portion of the anchor portion extending inwardly and proximally of theengaging members of the medical device are depicted in FIGS. 45-47.

In another embodiment, an anchor hub 774 may include a second tissuegrowth member 776 formed as a sock-like structure. Such a sock-likestructure was previously described with respect to an embodiment shownin FIG. 19. The sock like structure effectively provides a covering atthe proximal end of the anchor hub 774 and hub 752 to promote tissuegrowth and to assist in preventing emboli from migrating from the hub752. The second tissue growth member 776 may be pulled over the proximalend of the anchor hub 774 and maintained at that position with a spring778, the spring being held within a notch (not shown) in the anchor hub774. The second tissue growth member 776 can be formed of similarmaterials as the tissue growth member 762 of the occluder portion 605such as, for example, polyurethane foam and/or ePTFE.

In another embodiment, the hub 752 may include multiple guides 780extending longitudinally within an inner surface of the hub 752. Theguides 780 may be sized and configured in a spaced arrangement so that,as the anchor hub 774 is moved between an anchor-retracted position andan anchor-deployed position the anchor loops 748 may be relativelyaligned and substantially maintained from snagging each other orotherwise becoming tangled and intertwined. The guides 780, in oneembodiment, may include elongated nubs each extending longitudinallybetween a proximal opening and a distal opening of the hub. In anotherembodiment, one or more nubs (not shown) extending along the anchorloops 748 may be employed as a guide to properly align the anchor loops748 as they are displaced through the hub 752. Further, in anotherembodiment, a loop arrangement (not shown) may be utilized as a guide toallow the anchor loops 748 to slide through the loop arrangement forproper alignment when moving through the hub 752. In another embodiment,the anchor loops 748 are individually configured to maintain a generallyplanar configuration or a substantially flat configuration such that theanchor loops 748 may be configured to resist movement out of plane ofthe generally planar configuration. Such resistance from movement out ofplane also may assist in proper alignment of the anchor loops 748 movingthrough the hub 752.

As in previous embodiments, the anchor loops 748 may include a coiledwire 782 or other member. The coiled wire 782 may include a wire wrappedaround a portion of the anchor loops 748 in a coil configuration. Such acoiled wire 782 may provide additional traction with tissue in the LAAas well as provide additional surface area contact with tissue in theLAA and promote tissue growth thereto. Further, the coiled wire 782provides a safety mechanism in the event an anchor loop 748 fracturesfrom the anchor loop undergoing unpredictable stress/strain between theretracted and deployed configurations. Such a coiled wire 782 cansubstantially contain any fracture of a given anchor loop 748 within thecoiled wire 782 itself. In an embodiment that includes the coiled wire782, the engaging members 766 may extend a longer length for properclearance beyond the coiled wire 782 as previously discussed. As inprevious embodiments, the engaging members 766 extend at an angle andwith a blunt peak so as to substantially inhibit puncturing or piercingof the tissue, though they may be configured to aggressively engagetissue when the medical device 602 is deployed and moved or tuggedproximally or toward the ostium of the LAA to substantially preventmigration therefrom.

As previously noted, the medical device 602 may be coupled to the handlesystem 610 (FIG. 21) via the occluder tethers 628 and the anchor tether630 (see FIG. 21C). The occluder tethers 628 and the anchor tethers 630may be coupled to the eyelets 730 of the medical device 602 with tetherwires (shown as dashed line), the tether wires being the directinterconnection to the medical device 602.

The catheter system 608, as previously described and set forth withrespect to FIG. 21C, may extend through the sheath 604, as depicted inFIGS. 38 and 38A. The catheter system 608, as previously described, mayinclude the catheter 622 with the central lumen 624 and peripherallumens 626 configured to house the respective anchor tether 630 and theoccluder tethers 628, the anchor tethers 630 including the anchor pusher632 and the occluder tethers 628 including occluder pushers 636. Theanchor pusher 632 or anchor coil may be configured so as to exhibitsufficient axial compressive strength to push the anchor portion 603from the anchor-retracted position (see FIG. 37) to the anchor-deployedposition. The catheter 622 and the occluder pushers 636 may beconfigured to provide axial strength or compressive strength to push themedical device 602 through the sheath 604. The occluder pushers 636 mayprovide axial strength or compressive strength when deploying theoccluder tethers 628 from the catheter 622 or, otherwise, employing thefloat feature. As previously set forth, each of the occluder tethers 628and the anchor tether 630 may include tether wires (shown as dashedlines in FIG. 38 and as the first wire 640 and second wire 642 in FIG.38A) that are directly connected to the medical device 602. The tetherwires may be configured to facilitate pulling or retracting of themedical device 602 and are in tension when employed for such retraction.For example, when pulling the occluder portion 605 into the loader 754(FIG. 21) or into the sheath 604, the tether wires for the occludertether 628 maintain the position of the medical device 602 while theloader 754 or the sheath 604 are displaced relative to the medicaldevice 602 to enable the medical device 602 to become constrained withinthe sheath 604. Similarly, the tether wires for the anchor tether 630are configured to pull the anchor portion 603 from the anchor-deployedposition to the anchor-retracted position (FIG. 37), within the catheter622, as depicted with arrow 784.

Referring briefly to FIG. 39, a cross-sectional view of one eyelet 730of the medical device 602 is shown, to which a tether may be connected.As depicted, the tether (which may be the occluder tether 628 or theanchor tether 630) may only be coupled to the medical device via thetether wires. The tether wires may include a first wire 640 and a secondwire 642.

In one embodiment, the first wire 640 may be stainless steel and thesecond wire 642 may be Nitinol, however, other suitable biocompatiblematerials for the wires may be employed. The first wire 640 may beutilized as a pull wire and the second wire 642 may be utilized as a pinwire. The first wire 640 may be folded over at a mid portion, the midportion defining a loop 728 that extends through the eyelet 730. Thesecond wire 642 may be positioned to extend through the loop 728depicted as being under the eyelet 730. The first wire 640 may then becinched somewhat tight to thereby couple the first wire 640 and thesecond wire 642 to the medical device 602. Release of the tether wiresfrom the medical device 602 may be employed by first pulling on thesecond wire 642, as indicated by arrow 732, until the second wire hasretracted through the loop 728 of the first wire 640, after which, thefirst wire 640 may then be pulled from the eyelet 730, thereby,disconnecting the tether wires from the medical device 602. Additionaldescription of releasing the medical device by pulling the second wire642 before the first wire 640 is set forth above with respect to FIGS.24B and 24C.

With reference now to FIG. 40, the medical device 602 is shown with thecatheter 622 (and the sheath 604) retracted to expose and deploy distalportions of the occluder tethers 628 and the anchor tether 630,previously set forth as the float feature and enabled by moving thefloat handle portion 616 to the third handle position of the handlesystem (see FIGS. 21 and 21B). This float feature may be employed toenable a physician to assess the position and stability of the medicaldevice 602 in the LAA without placing unnecessary torque or lateralforces on the medical device 602 and potentially damaging the tissue inthe LAA. For example, once the anchor portion 603 is deployed, thephysician may retract the catheter 622 from the medical device 602 whilemaintaining interconnection to the medical device 602 via the tethers628, 630. The physician can then observe the medical device in aposition that is closer to that which will occur when the device isreleased and can also conduct a push/pull test on the medical device 602and view, through imaging techniques, the tethers 628, 630 bowing andthe medical device 602 slightly contorting. If the medical device 602 isdislodged from the LAA, the device may easily be recaptured by advancingthe catheter 622, retracting the anchor portion 603 and advancing thesheath 604 over the occluder portion 605 by employing the previouslydescribed handle system functions. The medical device 602 can thenreadily be re-positioned and anchored following the steps previously setforth. If the physician finds the device 602 is properly seated in theLAA after conducting a push/pull test, the physician can then releasethe tether wires from the medical device 602, as described herein.

As previously discussed, the frame segments of the medical device 602may include tapers or changes in cross-section to provide desiredstructural characteristics and performance. For example, as seen in FIG.38, the width of the anchor loops 748 may taper along their lengths. Itis noted that the width is indicated as “W” in various drawing figuresherein and may also be referred to as a radial width due to itsdimension having a radial directional component. In the embodiment shownin FIG. 38, the anchor loops exhibit a relatively thick width at theirradially inner ends or second end 751 and taper to a thinner width asthey extend to the curved portion (i.e., near the location where thecoils 768 terminate at a radially inner position), such as at the secondwire-connect portion 380 (FIG. 11A). In one embodiment, this taper maybe gradual from a width of approximately 0.015 inch to a width ofapproximately 0.008 inch. Extending past the second wire-connectportion, the anchor loop 748 may step up its width again at thislocation and then vary its width throughout the curved portion of theloop 748 (i.e., throughout the length to which the coil 768 isattached). In one example, the smallest width throughout the curvedportion may be approximately 0.003 inch at a location approximatelymidway through the length of the curved portion. The anchor loop 748 maythen taper back to a thicker width as extends back toward the hub fromits thinnest section. In such an embodiment, the depth of the anchorloop (i.e., the dimension measured into the plane of the page) mayremain constant. It is noted that the depth is indicated as “D” invarious drawing figures included herein and is also referred to as acircumferential depth due to its dimension in a generallycircumferential direction about the medical device. In one embodiment,for example, the depth may be approximately 0.017 inch. In other words,if the anchor loop 748 is cut from a sheet of material (e.g., Nitinol),the sheet of material may be 0.017 inch thick in this exampleembodiment.

Further, for example, the occluder frame segments 750 may also includeat least one taper along a portion of the length thereof. In oneembodiment, the width may taper from the proximal end coupled to the hubtoward the distal end along at least a portion of the occluder framesegment. By tapering portions of the frame segments of the occluderportion 605 and the anchor portion 603 minimize predictable andunpredictable stresses that may be placed on such frame segments,thereby, limiting potential for fractures in the frame segments. Ofcourse, as known by one of ordinary skill in the art, the above-noteddimensions may vary slightly, for example within acceptable tolerances,through the electro-polishing processes conducted on the frame segments.Such electro-polishing of the frame segments further minimizes potentialfractures in the frame segments.

It is also noted that the anchor loops 748 may be defined to exhibitdesired aspect ratios (i.e., depth (measured into the page in FIG. 40)vs. width (measured substantially transversely to depth). In oneembodiment, the anchor loops 748 may include a portion that exhibits adepth-to-width aspect ratio of at least approximately 2:1. In anotherembodiment, the anchor loops 748 may include portions that exhibit adepth-to-width aspect ratio of between approximately 1.1:1 andapproximately 5.7 to one. However, in other embodiments, the anchorloops 748 may include portions having depth-to-width aspect ratiosbetween approximately 1:1 and approximately 12:1. Further, thedepth-to-width aspect ratio for the occluder frame segments 750 along aportion of the length thereof may be at least approximately 2:1, but mayinclude a range of between approximately 1:1 and approximately 4:1 alongthe length of the occluder frame segments 750. In one embodiment, theaspect ratio for the occluder frame segments 750 may range between 1:1and 12:1 along the length of the occluder frame segments 750.

In another embodiment, the medical device 602 may include differentsizing options, such as a small size, a medium size and large size. Suchsizing options may primarily be measured by way of the anchor portion603, in a fully expanded state, and attached to the hub 752. Forexample, each anchor frame segment of the anchor portion 603 may includea length and a height, the length being the distance from the proximalend of the hub to the distal most end of the anchor loops 748 and theheight being the lateral distance, relative and perpendicular to thelength, between the anchor loops at, for example, where the anchor loopscontact the occluder portion 605. The height of the anchor portion 603for the different sizing options may include, for example, 21 mm, 28 mmand 35 mm for the small, medium and large sizes, respectively. Thelength of the anchor portion 603 for the different sizing options mayinclude 18 mm, 22 mm and 25 mm for the small, medium and large sizes,respectively. Of course, these sizing options may vary and the presentinvention is not limited to such sizing options.

Referring now to FIGS. 41 and 41A, a distal portion 804 of a catheter802 configured to articulate at the distal portion 804 thereof is shown.Such a catheter 802 may be the catheter described in the aboveembodiment, but also may be the sheath described above. The catheter 802may define a central lumen 806 and multiple peripheral lumens 808, suchas four peripheral lumens, each extending along a longitudinal length ofthe catheter 802. Further, within the distal portion 804 of the catheter802, the catheter 802 may define slots 810 or notches extendinglaterally therethrough between an outer surface and an inner surface ofthe catheter 802. Such slots 810 may be defined in columns, such as fourcolumns, along the distal portion 804 of the catheter 802 with two setsof opposing slots 810 in a staggered configuration such that adjacentcolumns of slots 810 are staggered relative to each other. The slots 810can define a slit-like configuration being wider in the middle andnarrower at the opposing ends of the slots. A variety of slotconfigurations may be employed, such as crescent shape, v-shaped,helical shaped or any other suitable shaped slot. With this arrangement,the slots 810 facilitate loosening the transverse strength of the distalportion 804 of catheter 802 to allow greater flexibility therein whilesubstantially maintaining the axial strength of the distal portion 804of the catheter 802.

Further, the catheter 802 may include wires 812 or other structuralmembers extending through the peripheral lumens 808 of the catheter 802.Such wires 812 may be fixed to a distal end 814 of the catheter 802 by,for example, securing the wires 812 to a plate 816. The plate 816 mayalso include openings 818 corresponding with the peripheral lumens 808through which ends of the wires 812 may be secured. The plate 816 may besecured to the distal end 814 of the catheter 802 by way of tensionapplied to the plate by the wires 812, or by other, independent meansincluding, for example, adhesive. The central lumen 806 of the catheter802 may be utilized for delivering a medical device for permanent orshort term placement, or for any other suitable purpose, such asintroducing a substance, retrieving a device or unwanted substance fromthe vasculature, providing passage for another catheter, or any othersuitable purpose where an articulating catheter may be employed.

Referring to FIGS. 42 and 42A, the catheter 802 may be coupled to anarticulating handle system 830. The handle system 830 may include anarticulating handle member 832, such as a universal joint or any othersuitable articulating member, positioned between a distal handle portion834 and a proximal handle portion 836. Each of the distal handle portion834 and the proximal handle portion 836 may define a first bore 838 anda second bore 840, respectively, axially extending through theirrespective portions and configured to be axially aligned relative toeach other. The catheter 802 may axially extend through the handle 830,namely, the first bore 838 of the distal handle portion 834 and throughat least a portion of the second bore 840 of the proximal handle portion836 in a fixed relationship therewith. Further, between the distalhandle portion 834 and the proximal handle portion 836, the handlesystem 830 may include a flexure member 842 positioned within oradjacent the articulating handle member 832.

As shown in FIGS. 42A and 43, the flexure member 842 may include atubular configuration with multiple spaced channels 844 definedlaterally through a periphery of the tubular configuration. The flexuremember 842 may be a resilient member sized and configured to bend orcontort as the articulating handle member 832 is manually articulated.The flexure member 842 may include a central opening 846 extendingthrough the flexure member 842 with peripheral openings 848 extendingalong the periphery of the flexure member 842 and corresponding with, orextending substantially parallel to, an axis of the central opening 846.Such peripheral openings 848 may be sized and configured to support andguide the wires 812 therethrough and the central opening 846 may besized and configured to be positioned over the catheter 802 that extendstherethrough.

With respect to FIG. 42A, the catheter 802 may define openings 850, at aproximal portion of the catheter 802 within the distal handle portion834, through which the wires 812 may extend. Further, first tubing 852,with a lumen defined therethrough, extends outwardly and proximally fromthe openings 850 and through the distal handle portion 834 and isconfigured such that the wires 812 extend through the lumens of thefirst tubing 852. For example, the four wires 812 may extend through thecatheter 802 through the four openings 850 and through the correspondingfirst tubing 852, one wire 812 extending through each opening 850 and acorresponding first tubing 852. The openings 850 may be defined in thecatheter 802 at positions opposite another opening such that eachadjacent opening may be radially positioned approximately ninety degreesfrom the other opening. Of course, if there are more or less wires andcorresponding openings than the above example of four wires and fouropenings, such openings may be equally spaced about the catheter atother angular frequencies.

Further, as previously set forth, the wires 812 may be channeled fromthe openings 850 to extend outwardly and proximally through the firsttubing 852 to a larger spaced relationship as compared to the spacing ofthe wires 812 within the catheter 802. The wires 812 continue to extendproximally, through the peripheral openings 848 (FIG. 43) of the flexuremember 842 and through the proximal handle portion 836. Within theproximal handle portion 836, each wire 812 may extend through at leastone second tubing 854.

Referring to FIGS. 42A and 44, the proximal handle portion 836 may alsoinclude a wire engaging member 856. The wire engaging member 856 mayinclude a rotatable knob 858, a ramped surface—referred to herein as aramp 860—, multiple spheres 862 and an inner member 864. The ramp 860may be an inner surface of the knob 858 and may include a detent surface866 defined therein exhibiting various sloping, recessed portionsextending radially within the ramp 860 that are sized and configured tocorrespond with and move the spheres 862 in a tightened or clampingrelationship with the wires 812. Further, the inner member 864 mayinclude a recess 868 through which the wires 812 extend, the recess 868also being positioned and configured to receive a portion of the spheres862. With this arrangement, the detent surface 866 corresponds with thespheres 862 such that, when rotating the knob 858, the detent surface866 rolls over the spheres 862 and is configured to clamp the wiresagainst the inner member 864. In this manner, the wires 812 may becomeplaced in a fixed relationship with the proximal handle portion 836.When the knob 858 is rotated to a disengaged position, the wires 812 maybe loosened within the second tubing 854 and be fixed only at the distalportion 804 of the catheter 802. Further, as previously set forth, thewires 812 are channeled to extend in a spaced relationship through thehandle system 830 and, in particular, through the flexure member 842.The increased radially spaced relationship of the wires 812 facilitatesa wider travel for the wires 812 to articulate the distal portion 804 ofthe catheter 802 than if the wires 812 exhibited spacing similar to thespaced distance of the wires 812 within the catheter 802.

More specifically, for example, with respect to FIGS. 41 and 42A, if thedistal handle portion 834 is articulated downward, via the articulatinghandle member 832, the upper wire 812 a (i.e., the wire depicted as the“upper” wire in FIG. 42A) will be moved into tension within the flexuremember 842, while the lower wire 812 b will have less or no tension.This downward movement of the distal handle portion 834 and differencein tension between the upper wire 812 a and the lower wire 812 b willpull or articulate the distal portion 804 of the catheter 802 in anupward configuration (still considering the orientation of FIG. 42A) dueto the wires 812 being fixed within the proximal handle portion 836.

Similarly, upward movement of the distal handle portion 834 will placeor pull the lower wire 812 b in tension due to the flexibility of theflexure member 842, thereby, articulating the distal portion 804 of thecatheter 802 downward. Likewise, the wires 812 c and 812 d (only shownin FIG. 44) channeled through the sides of the flexure member 842 willfacilitate articulation of the distal portion 804 of the catheter 802laterally with a similar arrangement. In this manner, fixing the wires812 in the proximal handle portion 836 and spacing the wires 812 throughthe flexure member 842 facilitates the travel needed for effectivearticulation of the distal portion 804 of the catheter 802 in theopposite direction than the direction the distal handle portion 834 isarticulated via the articulating handle member 832. It is noted thatalthough the above-description of an articulating handle system 830 hasbeen provided for a catheter, such as the catheter for delivering themedical device set forth above, the articulating handle system may alsobe employed with the sheath of the medical device delivery systempreviously set forth, or employed for any suitable purpose for which anarticulating catheter may be desired.

Referring now to FIG. 45, medical device 900 is shown according toanother embodiment of the present invention. It is noted that only aportion of the medical device 900 is shown in cross-section. The medicaldevice 900 includes an occluder portion 902 and an anchor portion 904,similar to various embodiments previously described herein. The occluderportion 902 may include a plurality of occluder frame segments 906 and atissue growth member 908. The anchor portion 904 may include a pluralityof anchor frame segments 910 having engagement members 912 or nubsthereon. The engagement members 912 may be similar to those describedwith respect to other embodiments provided herein. As with previouslydescribed embodiments, the occluder portion 902 and the frame portion904 may be separately and independently deployed.

An extension member 914 may be coupled to a distal end 916 of eachanchor frame segment 910 and extend inwardly and proximally fromadjacent the engagement members 912. For example, in one embodiment, theextension member 914 may include a filament or a wire coupled to aneyelet 918 (or other coupling member) associated with the frame segment910. The extension member 914 may be configured, for example, to extendproximally from the distal end 916 of the anchor segment 910 and througha hub portion 920 that couples the various occluder frame segments 906and anchor frame segments 910 together. In use, the extension members914 may be displaced proximally to retract the anchor frame segments 910for repositioning or recapture of the device 900. In one embodiment, theanchor frame segments 910 may be configured to be displaced primarilyradially inwardly upon proximal displacement of the extension members914. In another embodiment, the anchor frame segments 910 may beconfigured to roll into a catheter or other component of a deliverydevice, similar to other embodiments described herein.

Upon satisfactory deployment of the medical device 900 in an LAA, theextension members may be decoupled from the anchor frame segments 910.For example, the extension members 914 may be decoupled from theirassociated eyelets 918 and retracted from the device 900. In anotherembodiment, the extension members 914 may remain coupled with theeyelets 918 but trimmed or cut or released, such as at the proximal faceof the medical device 900. While the extension members 918 act asstructural members in tension to retract the anchor frame segments 910,they may also be configured to act as structural members in compressionto push against the anchor frame segments 910 in certain embodiments. Inthe case that the extension members 914 also act as compression members,they may be pivotally coupled with the anchor frame segment 910.

Referring to FIG. 46, a medical device 930 according to anotherembodiment is shown. The medical device 930 includes an anchor portionincluding multiple anchor frame segments 932 (only one is shown forconvenience) and an occluder portion with a tissue growth member 934coupled directly with the anchor frame segments 932. Engagement members936 may be formed on a distal and radially outward portion of the anchorframe segments 932. Extension members 938 may be coupled with the anchorframe segments 932 in a similar manner, and function substantially thesame as, those described with respect to FIG. 45. In this embodiment,when the medical device 930 is deployed, if the physician desires toreposition to a more preferred location within the LAA, the extensionmember 938 may be pulled proximally to move the engaging members 938from a tissue-engaging position to a tissue-nonengaging position. Thephysician may then reposition the occluder portion to a preferredposition and then release the extension member 938 to allow the anchorframe segments 932 to self expand to move the engaging members 936 tothe tissue-engaging position. This process may be repeated until thephysician is satisfied with the location of the medical device 930 and,then, proceed to releasing the medical device 930 similar to thatdescribed in previous embodiments.

Referring to FIG. 47, a medical device 950 according to anotherembodiment is shown. The medical device 950 may include an occluderportion and an anchor portion. The anchor portion may include multipleanchor frame segments 952 with engagement members 936 extending from aradial distal end portion of the frame segments 952. The occluderportion may include a tissue growth member 934 coupled to a proximalface of the multiple anchor frame segments 952. In this embodiment, themedical device 950 is substantially the same as shown and described withrespect to FIG. 46, except that instead of a discrete extension member(e.g., extension member 938 shown in FIG. 46), the anchor frame segment952 includes a loop portion 954 (that exhibits an extension portionextending inwardly and proximally from adjacent the engagement members952) that acts as, or functions similar to, the discrete extensionmember of the embodiments shown in FIGS. 45 and 46.

While the invention may be susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and have been described in detail herein.However, it should be understood that the invention is not intended tobe limited to the particular forms disclosed. Rather, the inventionincludes all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the followingappended claims.

What is claimed is:
 1. A method of modifying a left atrial appendage ofa heart, the method comprising: advancing a medical device with acatheter of a delivery system through a vasculature and into the leftatrial appendage of the heart, the medical device including a frameworkextending between a primary hub and a secondary hub, the primary hub andthe secondary hub having a common axis; deploying the framework adjacentthe left atrial appendage from a constricted position to a deployedposition so that the secondary hub is moveable along the axis relativeto the primary hub such that the secondary hub remains proximal a distalend of the framework; securing the framework to tissue in the leftatrial appendage with engaging members positioned on the frameworkproximal the distal end of the framework, the framework at a distal sidethereof extending radially and distally toward the distal end, and turnsto extend radially and proximally inward toward the secondary hub; andreleasing the catheter from the medical device and withdrawing thedelivery system from the heart to permanently leave the medical devicein the left atrial appendage.
 2. The method according to claim 1,wherein the deploying the framework comprises deploying the frameworkwith a tissue growth member positioned over a proximal side of theframework.
 3. The method according to claim 1, wherein the deploying theframework comprises deploying an occluder portion of the medical deviceand separately deploying an anchor portion of the medical device.
 4. Themethod according to claim 1, wherein the deploying the frameworkcomprises deploying the framework from the constricted position suchthat the framework is at least partially constricted within thecatheter.
 5. The method according to claim 1, wherein the deploying theframework comprising moving a portion of the framework through a bore ofthe primary hub.
 6. The method according to claim 1, further comprisingretracting the framework such that the engaging members move away fromthe tissue of the left atrial appendage and such that the frameworkmoves to a retracted position.
 7. The method according to claim 1,wherein the deploying the framework comprises deploying an occluderportion of the medical device; and deploying an anchor portion of themedical device, subsequent to the occluder portion being deployed. 8.The method according to claim 1, wherein the deploying the frameworkcomprises deploying an occluder portion having a tissue growth memberpositioned over a proximal side of the medical device.
 9. The methodaccording to claim 1, wherein the deploying the framework comprisesdeploying the framework with a porous polymeric material positioned overa proximal side of the framework.
 10. The method according to claim 1,wherein the deploying the framework comprises deploying the frameworkwith a porous material positioned over a proximal side of the framework.11. A method of modifying a left atrial appendage (“LAA”) of a heart,the method comprising: advancing a medical device with a catheterthrough a vasculature and to the left atrial appendage, the medicaldevice having a framework extending between a primary hub and asecondary hub, the primary hub and the secondary hub having a commonaxis; deploying the framework adjacent the left atrial appendage from aconstricted position to a deployed position so that the secondary hub ismoveable along the axis relative to the primary hub such that thesecondary hub remains proximal a distal end of the framework; andsecuring the framework to tissue of the left atrial appendage withengaging members positioned on the framework proximal the distal end ofthe framework, the framework at a distal side thereof extending radiallyand distally toward the distal end, and turns to extend radially andproximally inward toward the secondary hub; and releasing the medicaldevice from the catheter with the framework of the medical deviceremaining secured to the tissue of the left atrial appendage of theheart.
 12. The method according to claim 11, wherein the deploying theframework comprises distally moving the secondary hub along the axis tosecure the engaging members of the framework into the tissue of the leftatrial appendage.
 13. The method according to claim 11, wherein thesecuring the framework comprises retracting the engaging members fromthe tissue by moving the secondary hub proximally and re-securing theframework to the tissue of the left atrial appendage by moving thesecondary hub distally.
 14. The method according to claim 11, whereinthe deploying the framework comprises deploying the framework with atissue growth member positioned over a proximal side of the framework.15. The method according to claim 11, wherein the deploying theframework comprises deploying an occluder portion of the medical deviceand separately deploying an anchor portion of the medical device. 16.The method according to claim 11, wherein the deploying the frameworkcomprises deploying the framework from the constricted position suchthat the framework is at least partially constricted within thecatheter.
 17. The method according to claim 11, wherein the deployingthe framework comprising moving a portion of the framework through abore of the primary hub.
 18. The method according to claim 11, whereinthe deploying the framework comprises deploying the framework with aporous polymeric material positioned over a proximal side of theframework.
 19. The method according to claim 11, wherein the deployingthe framework comprises deploying the framework with a porous materialpositioned over a proximal side of the framework.
 20. The methodaccording to claim 11, further comprising withdrawing the catheter fromthe left atrial appendage and the vasculature.